ALK fusion

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Open a row for the exact indication and source.

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

1. Roche 6
2. Pfizer 4
3. CSPC 3
4. Shenzhen TargetRx 3
5. Novartis 2
6. AstraZeneca 2
7. Nuvalent 2
8. Henlius 2
9. Kelun-Biotech 2
10. BioNTech 2
11. Bristol Myers Squibb 2
12. Ascentage Pharma Group 2
13. Dizal Pharmaceuticals 1
14. Genmab 1
15. Gilead Sciences 1

Phase 1 Phase 2 Phase 3 Phase 4 No phase

Trials

Matched automatically from registry text, so a few trials may only mention ALK fusion rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

192 of 482 trials shown

1. Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC

   Not yet recruiting Phase 4 Qiming Wang Started 2026 NCT07671560

   Combined group of ensatinib and arotinib

   Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC

   ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib

2. Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / Mixed

   Not yet recruiting Phase 4 Hunan Cancer Hospital Started 2026 NCT07674368

   Recaticimab

   Positive ALK fusion confirmed by genetic testing;

   ALK Fusion-positive Non-small Cell Lung Cancer

3. Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study

   Not yet recruiting Phase 4 Fujian Medical University Union Hospital Started 2025 NCT06785584

   Ensartinib FDA

   Alk-positive as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), n…

   ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC), MPR, Neoadjuvant Therapy

4. Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics

   Not yet recruiting Phase 4 The First Affiliated Hospital of Guangzhou Medical University Started 2025 NCT06893354

   lorlatinib FDA EUlorlatinib plus chemotherapy FDA EU

   Documented ALK-fusion positive（ Ventana , assessed by a local laboratory）

   NSCLC

5. Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

   Active, not recruiting Phase 4 Guangdong Association of Clinical Trials Started 2024 NCT06282874

   Lorlatinib FDA EU

   Histologically or cytologically confirmed ALK-positive NSCLC.

   Carcinoma, Non-Small-Cell Lung, Brain Metastases, Leptomeningeal Metastasis

6. Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

   Recruiting Phase 4 University Medical Center Groningen Started 2022 NCT05525338

   Alectinib FDA EU

   Documented ALK rearrangement based on an EMA approved test

   Status may be outdated, last updated 2024-05-13Drug Monitoring, Carcinoma, Non-Small-Cell Lung, Lung Cancer, Anaplastic Lymphoma Kinase Gene Mutation

7. Lorlatinib Continuation Study

   Active, not recruiting Phase 4 Pfizer Started 2021 NCT05144997

   Lorlatinib FDA EU

   …CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORL…

   Non-Small-Cell Lung Cancer, NSCLC

8. Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

   Active, not recruiting Phase 4 Novartis Started 2015 NCT02584933

   ceritinib FDA EU

   An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Jud…

   ALK Positive Malignancies

9. Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial

   Recruiting Phase 3 National Cancer Institute (NCI) Starts 2027 NCT07388524

   AtezolizumabAtezolizumab and Recombinant Human Hyaluronidase

   No EGFR exon 19 deletion (del) or L858R mutation or ALK fusion

   Lung Non-Small Cell Carcinoma

10. Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

    Active, not recruiting Phase 2/3 Medicine Invention Design Started 2026 NCT05987956

    ALECENSA - alectinib hydrochloride capsule FDA EU

    Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:

    ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

11. Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma

    Not yet recruiting Phase 3 Guangdong Association of Clinical Trials Started 2025 NCT06858410

    lorlatinib FDA EU

    Study Population: Patients with histologically or cytologically confirmed diagnosis of ALK-positive, lung adenocarcinoma who present with locally advanced, unresectable (Stage III) disease …

    Neoadjuvant Non-Small Cell Lung Cancer

12. Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

    Recruiting Phase 3 AstraZeneca Started 2025 NCT07291037

    Datopotamab deruxtecan (Dato-DXd)Docetaxel

    …n 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK, and ROS1 genomic alterations.

    Non-small Cell Lung Cancer (NSCLC)

13. Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

    Recruiting Phase 3 Nuvalent Started 2025 NCT06765109

    Neladalkib (NVL-655)Alectinib FDA EU

    Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood

    Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive

14. A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)

    Active, not recruiting Phase 3 mAbxience Research S.L. Started 2024 NCT06687369

    MB12 (Proposed Pembrolizumab Biosimilar)EU-sourced Keytruda®US-sourced Keytruda®PemetrexedCarboplatinCisplatin

    …ode Metastasis \[TNM\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC.

    Non Squamous Non Small Cell Lung Cancer

15. A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

    Not yet recruiting Phase 3 Shouyao Holdings (Beijing) Started 2024 NCT06254599

    SY-3505 CapsulesCrizotinib Capsules FDA EU

    Previously confirmed by a local laboratory as ALK fusion-positive (patients included based on previously confirmed ALK fusion-positive test result…

    Status may be outdated, last updated 2024-02-12Non-small Cell Lung Cancer

16. Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer

    Not yet recruiting Phase 3 Tianjin Medical University Cancer Institute and Hospital Started 2024 NCT06704620

    DiphenhydramineTislelizumabPemetrexedAlbumin paclitaxelCarboplatinCisplatin

    Patients (adenocarcinoma and adenosquamous carcinoma) with wide type EGFR and negative ALK fusion gene can enroll into the trial;

    Advanced and Metastatic NSCLC

17. A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

    Recruiting Phase 3 Dizal Pharmaceuticals Started 2024 NCT07234162

    GolidocitinibChidamideGemcitabine

    …OS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell l…

    Peripheral T-cell Lymphoma

18. Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study

    Recruiting Phase 3 Gustave Roussy, Cancer Campus, Grand Paris Started 2023 NCT05692999

    Pembrolizumab 200 mg Q6WPemetrexed 500 mg/m^2 Q3WPembrolizumab 200 mg Q3W or 400 mg Q6W

    In the presence of an EGFR mutation, an ALK or ROS1 rearrangement the patient must have received at least one specific targeted therapy line.

    Metastatic Non-squamous Lung Cancer

19. Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma

    Recruiting Phase 3 Universität des Saarlandes Started 2023 NCT05820841

    R-miniCHOP + AcalabrutinibR-miniCHOP

    ALK+ large B-cell lymphoma

    Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma

20. DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

    Recruiting Phase 2/3 Cancer Research UK Started 2023 NCT05770037

    Alectinib FDA EU

    Confirmed diagnosis of an ALK-positive malignancy using an analytically validated next-generation sequencing method.

    Haematological Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type

21. TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 3 Shenzhen TargetRx Started 2023 NCT06082635

    TGRX-326Crizotinib FDA EU

    Diagnosed as incurable stage IIIB - IV ALK-positive NSCLC;

    Non Small Cell Lung Cancer

22. A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 3 Roche Started 2022 NCT05170204

    Alectinib FDA EUEntrectinibDurvalumab

    …rformed prior and within 42 days for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) of the first dose of concurrent chemoradiotherapy (cCRT) or sequential chemoradiotherapy…

    Non-Small Cell Lung Cancer

23. Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 Gilead Sciences Started 2022 NCT05502237

    ZimberelimabDomvanalimabPembrolizumabCarboplatinCisplatinPaclitaxel

    … test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.

    Non-small Cell Lung Cancer

24. Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

    Active, not recruiting Phase 2/3 SWOG Cancer Research Network Started 2022 NCT05096663

    DexamethasoneDocetaxelGemcitabineNogapendekin AlfaPembrolizumabPemetrexed

    EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at …

    Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8

25. Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL

    Active, not recruiting Phase 3 CSPC Started 2021 NCT04668690

    Mitoxantrone Hydrochloride Liposome InjectionChidamide

    ALK+ systematic anaplastic large T-cell lymphoma (ALCL, ALK+);

    Peripheral T Cell Lymphoma

26. Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

    Active, not recruiting Phase 3 Incyte Started 2021 NCT04824092

    TafasitamabLenalidomideRituximabCyclophosphamideDoxorubicinVincristine

    Anaplastic lymphoma kinase (ALK)-positive large BCL

    Diffuse Large B-cell Lymphoma

27. Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC

    Active, not recruiting Phase 3 Shanghai Fosun Pharmaceutical Industrial Development Started 2021 NCT06569420

    ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test.

    Status may be outdated, last updated 2024-08-26Non-Small Cell Lung Cancer, ALK-positive, SAF-189s

28. Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

    Recruiting Phase 3 Children's Oncology Group Started 2018 NCT03126916

    BusulfanCarboplatinCisplatinCyclophosphamideDexrazoxane HydrochlorideDinutuximab

    PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH …

    Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma

29. A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 Roche Started 2018 NCT03456076

    AlectnibCisplatinVinorelbineGemcitabinePemetrexedCarboplatin

    Documented ALK-positive disease according to an FDA-approved and CE-marked test

    Carcinoma, Non-Small-Cell Lung

30. PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer

    Active, not recruiting Phase 3 UNICANCER Started 2018 NCT03774732

    PembrolizumabChemotherapy

    Non-squamous NSCLC with targetable tumor mutations, activating EGFR mutations or ALK translocation Note: documentation of these mutation for non-squamous histology is mandatory as standard…

    Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-Small Cell Carcinoma of Lung, TNM Stage 4

31. A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

    Active, not recruiting Phase 3 Pfizer Started 2017 NCT03052608

    Lorlatinib FDA EUCrizotinib FDA EU

    Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC

    Carcinoma, Non-Small-Cell Lung

32. eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

    Active, not recruiting Phase 3 Xcovery Holdings Started 2016 NCT02767804

    X-396 (ensartinib) FDAcrizotinib FDA EU

    …age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive by an FDA-approved assay performed centrally.

    Non-small Cell Lung Cancer

33. Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

    Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2015 NCT02193282

    Erlotinib Hydrochloride

    Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105

    Lung Non-Squamous Non-Small Cell Carcinoma, Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Non-Small Cell Carcinoma AJCC v7

34. Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

    Active, not recruiting Phase 3 ECOG-ACRIN Cancer Research Group Started 2015 NCT02201992

    Crizotinib FDA EU

    …K gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 \[EML4\]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay a…

    ALK Gene Rearrangement, ALK Gene Translocation, ALK Positive, Stage IB Non-Small Cell Lung Carcinoma AJCC v7

35. Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

    Not yet recruiting Phase 1/2 China Medical University Hospital Started 2026 NCT07560410

    Alectinib FDA EU

    Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

    Bone Cancer

36. Multidisciplinary Treatment of Stage III ALK+ NSCLC With Neoadjuvant Alectinib and Chemotherapy

    Not yet recruiting Phase 2 Wen-zhao ZHONG Started 2026 NCT07573696

    After neoadjuvant alpelisib combined with chemotherapy, a multidisciplinary decision was made

    …sults as ordered by a healthcare provider from a high-quality and appropriately validated ALK fusion test on tumor tissue performed in a Clinical Laboratory Improvement Amendments Certified …

    Nonsmall Cell Lung Cancer Stage III

37. Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC

    Recruiting Phase 2 Massachusetts General Hospital Started 2026 NCT07405190

    Ivonescimabcarboplatinpemetrexed

    ALK fusion: a third- or fourth-generation ALK TKI such as lorlatinib or neladalkib (NVL-655) iii.

    Lung Cancer (NSCLC), Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer (Non-Small Cell), Lung Cancer - Non Small Cell

38. Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations

    Not yet recruiting Phase 2 Shanghai Zhongshan Hospital Started 2026 NCT07829744

    Documented EGFR exon 20 insertion, ALK fusion, ROS1 fusion, MET exon 14 skipping alteration, RET fusion, or KRAS G12C mutation.

    Lung Cancer (NSCLC)

39. Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance

    Recruiting Phase 2 Gustave Roussy, Cancer Campus, Grand Paris Started 2026 NCT07483983

    ASP3082

    Patients who have known actionable genomic alterations (EGFR, BRAF, and MET mutations or ALK, ROS1, RET, NTRK fusions) must have exhausted the available targeted therapy and have experienced disease progress…

    Metastatic/Locally Advanced Non-Small-Cell Lung Cancer, Metastatic/Locally Pancreatic Ductal Adenocarcinoma

40. Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study

    Not yet recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026 NCT07365410

    FurmonertinibFurmonertinibcarboplatinpemetrexed

    Concurrent positive for other driver genes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation)

    Non-small Cell Lung Cancer (NSCLC), Brain Metastases, Furmonertinib, EGFR Mutation

41. Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

    Not yet recruiting Phase 2 Li Zhiming Started 2026 NCT07231250

    Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; Prednisone

    Anaplastic lymphoma kinasepositive large B-cell lymphoma

    DLBCL - Diffuse Large B Cell Lymphoma, Chemo-free Therapy, Bispecific Antibody

42. Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)

    Recruiting Phase 1/2 Tang-Du Hospital Started 2026 NCT07354061

    Ensartinib + Chemotherapy FDA

    Confirmed ALK fusion mutation by detection methods recommended by NCCN guidelines.

    NSCLC (Non-small Cell Lung Cancer)

43. MANTIS-RCC: Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell and Renal Medullary Carcinomas

    Not yet recruiting Phase 2 Fudan University Started 2026 NCT07816770

    ToripalimabAxitinib

    …e-deficient renal cell carcinoma, succinate dehydrogenase-deficient renal cell carcinoma, ALK-rearranged renal cell carcinoma, and renal cell carcinoma not otherwise specified or unclassified af…

    Metastatic Non-Clear Cell Renal Cell Carcinoma, Metastatic Renal Medullary Carcinomas

44. Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic NSCLC

    Not yet recruiting Phase 2 Se-Hoon Lee Started 2026 NCT07432984

    Tislelizumab

    …d disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.)

    Non Small Cell Lung Cancer

45. SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

    Recruiting Phase 2 Kelun-Biotech Started 2026 NCT07697586

    SKB264+SKB118

    …ermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.

    NSCLC

46. PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2026 NCT07416058

    QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

    ALK, ROS1, RET fusions

    Lung Adenocarcinoma

47. Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases

    Not yet recruiting Phase 2 Bing Xia Started 2026 NCT07875465

    PD-1/PD-L1 inhibitorsCombined Chemotherapy

    Cohort B: Advanced NSCLC with positive driver genes (EGFR/ALK/ROS1), disease progression during first-line targeted therapy.

    Liver Metastases, Non-Small Cell Lung Cancer, Colorectal Cancer (Diagnosis), Pancreatic Cancer Metastatic

48. A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC

    Recruiting Phase 1/2 TRIANA Biomedicines Started 2026 NCT07491497

    TRI-611

    Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)

    ALK-positive NSCLC, ALK-Positive Lung Cancer, ALK-positive Non-small Cell Lung Cancer

49. Adebrelimab Combined With SHR2554 in Relapsed/Refractory PTCL and NK/T-Cell Lymphoma

    Not yet recruiting Phase 1/2 Sun Yat-sen University Started 2026 NCT07615283

    Adebrelimab & SHR2554

    Systemic anaplastic large cell lymphoma (ALK+ and ALK-);

    Relapsed or Refractory Peripheral T Cell Lymphoma, NKTCL

50. A Multicenter Exploratory Clinical Study of Iruplaltinib Combined With Pemetrexed as Neoadjuvant Therapy for Resectable ALK-Positive Non-Squamous Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 First Affiliated Hospital of Fujian Medical University Started 2026 NCT07771764

    iruplaltinib and pemetrexed

    …ical Study of Iruplaltinib Combined With Pemetrexed as Neoadjuvant Therapy for Resectable ALK-Positive Non-Squamous Non-Small Cell Lung Cancer

    ALK-positive Non Small Cell Lung Cancer

51. Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2026 NCT07415005

    Lorlatinib FDA EU

    Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer

    Advanced Non-Small Cell Lung Cancer

52. A Phase 1/2 Study of SY-12321 in Patients With ALK-positive Advanced Malignancies

    Recruiting Phase 1/2 Shouyao Holdings (Beijing) Started 2026 NCT07810933

    SY-12321

    ALK positivity (ALK fusion and/or other meaningful mutations) must be confirmed by NGS testing performed at the cent…

    ALK Positive Advanced Malignancies

53. Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLC

    Not yet recruiting Phase 2 Guangdong Association of Clinical Trials Started 2026 NCT07750704

    Lorlatinib FDA EUsacituzumab tirumotecan plus lorlatinib FDA EU

    Confirmation of ALK fusion by tumor histology, cytology, or blood-based testing;

    ALK Positive Non-small Cell Lung Cancer

54. Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC

    Not yet recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China Started 2025 NCT07235306

    Ensartinib 225mg FDA

    ALK mutations assessed by FISH, IHC, or NGS

    NSCLC Stage III, Ensartinib, Chemoradiotherapy, ALK

55. Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy

    Recruiting Phase 2 Shanghai Junshi Bioscience Started 2025 NCT06868836

    JS207PemetrexedCarboplatin or cisplatinJS212

    …xon deletion mutation, 20 exon S768I or T790M mutation, 21 exon L858R or L861Q mutation), ALK fusion, ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion,…

    Non-squamous Non-small Cell Lung Cancer

56. Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

    Recruiting Phase 2 New York Medical College Started 2025 NCT07013565

    Vinblastine (Velban)Brentuximab vedotin (Adcetris)Nivolumab (Opdivo)

    Patients with relapsed or refractory histologically or cytologically proven ALK-positive anaplastic large cell lymphoma meeting Low or High Risk Criteria:

    Anaplastic Large Cell Lymphoma, ALK-Positive

57. Trial for Local Ablative Treatment (LAT) Optimization in Patients With Advanced Non-Small Cells Lung Cancer (NSCLC) Presenting an Anaplastic Lymphoma Kinase (ALK) Rearrangement Treated by Brigatinib

    Recruiting Phase 2 Groupe Francais De Pneumo-Cancerologie Started 2025 NCT06620835

    Blood samples for HematologyBlood samples for ChemistryBlood sample for liver function testsPregnancy test

    ALK rearrangements identified by a validated technique (either Immunohistochimy (IHC), fluorescence in situ …

    NSCLC

58. Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD

    Not yet recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2025 NCT06780839

    Ensartinib FDA

    Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD

    NSCLC, Stage I, II, IIIA, IIIB

59. A Phase I/II Study of Golidocitinib Combined with Pomalidomide in R/R PTCL

    Recruiting Phase 1/2 Sun Yat-sen University Started 2025 NCT06855823

    Golicitinib combined with Pomadomide

    … immunoblastic T cell lymphoma (AITL), NK/T cell lymphoma, anaplastic large cell lymphoma ALK positive (ALCL ALK+), anaplastic large cell lymphoma ALK negative (ALCL ALK-), enteropathy-associa…

    Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

60. Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy

    Recruiting Phase 2 Mayo Clinic Started 2025 NCT06834373

    Chimeric Antigen Receptor T-Cell TherapyGolcadomideRituximab

    ALK positive large B-cell lymphoma

    Large B-Cell Lymphoma With IRF4 Rearrangement, Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma, Recurrent ALK-Positive Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type

61. Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)

    Not yet recruiting Phase 1/2 Sun Yat-Sen University Cancer Center Started 2025 NCT07288814

    Mitoxantrone Hydrochloride Liposome & Enlonstobart

    Systemic anaplastic large cell lymphoma (ALK+ and ALK-);

    Relapsed or Refractory Peripheral T Cell Lymphoma

62. A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 2 Henlius Started 2025 NCT06907615

    HLX43 DOSE 1 (2.0 mg/kg)HLX43 DOSE 2 (2.5 mg/kg)

    Subjects with non-squamous NSCLC must have documented negative test results for EGFR and ALK alterations.

    Non Small Cell Lung Cancer

63. A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 1/2 BioNTech Started 2025 NCT07111520

    BNT326Pumitamig

    …ve no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase (ALK) gene rearrangements, or other genomic alterations for which targeted molecular therapies are available.

    Non-small Cell Lung Cancer

64. Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 West China Hospital Started 2025 NCT06779539

    Ensartinib FDA

    Patients confirmed as ALK fusion positive by RBK (NGS) test.

    Non-Small Cell Lung Cancer

65. Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer

    Not yet recruiting Phase 2 Nanjing First Hospital, Nanjing Medical University Started 2025 NCT06762327

    Ensartinib FDA

    Alk-positive or MET14 exon skipping mutation by IHC\\FISH\\NGS\\RT-PCR

    Solid Tumors

66. A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors

    Recruiting Phase 1/2 L & L Bio Co., Ltd., Ningbo, China Started 2024 NCT06468358

    LB1410LB4330

    1. non-squamous NSCLC must have documented test results of EGFR mutation, ALK fusion and ROS1 fusions, and the above driver genes must be wild type;

    Solid Tumor

67. Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC

    Recruiting Phase 2 Anhui Provincial Cancer Hospital Started 2024 NCT06714708

    Active comparator

    …required to undergo genetic testing, but subjects with known EGFR sensitive mutations and ALK rearrangements should not be included in the study.

    NSCLC, Neoadjuvant Immunotherapy, Low Dose Radiotherapy, Sintilimab

68. Chidamide Plus Golidocitinib in Relapsed/Refractory Peripheral T-Cell Lymphoma

    Not yet recruiting Phase 1/2 Peking University Cancer Hospital & Institute Started 2024 NCT06757387

    chidamide and golidocitinib

    …oimmunoblastic T-cell lymphoma (AITL), NK/T-cell lymphoma, anaplastic large cell lymphoma ALK-positive (ALCL ALK+), anaplastic large cell lymphoma ALK-negative (ALCL ALK-), enteropathy-associa…

    Peripheral T-cell Lymphoma

69. Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Peking University People's Hospital Started 2024 NCT06682884

    Lorlatinib 100 mg FDA EU

    Documented ALK-rearrangement mutation positive (assessed by a local laboratory)

    Neoadjuvant Non-Small Cell Lung Cancer

70. A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor

    Recruiting Phase 1/2 Huabo Biopharm Started 2024 NCT06758557

    HB0025PemetrexedPaclitaxelCarboplatin

    …vity mutations of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) translocation, who have experienced disease progression after standard treatment with TKI targeted drug…

    Advanced NSCLC, Advanced Endometrial Cancer

71. A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

    Active, not recruiting Phase 2 AstraZeneca Started 2024 NCT06008093

    DurvalumabTremelimumabPemetrexedPembrolizumabCarboplatinCisplatin

    …ants must have tumors that lack activating epidermal growth factor receptor mutations and ALK fusions.

    Carcinoma, Non-Small-Cell Lung

72. Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

    Recruiting Phase 2 Sun Yat-sen University Started 2024 NCT06547203

    CetuximabToripalimabIrinotecan

    …tations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions.

    Status may be outdated, last updated 2024-08-09Colorectal Cancer Metastatic

73. A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib

    Recruiting Phase 2 Centro di Riferimento Oncologico - Aviano Started 2024 NCT06378892

    Lorlatinib FDA EU

    Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC.

    Status may be outdated, last updated 2024-04-23Non Small Cell Lung Cancer Metastatic, ALK Gene Mutation

74. Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax

    Recruiting Phase 2 University of Rochester Started 2024 NCT06262321

    …l Lung Cancer (NSCLC) without targetable/oncogene driven mutations (i.e., EGFR mutations, ALK-rearrangement, ROS1 rearrangement).

    Stage 4 NSCLC, Radiotherapy

75. Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC

    Recruiting Phase 1/2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2024 NCT05950139

    Peptide vaccine

    Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry …

    NSCLC Stage IV, ALK Fusion Protein Expression

76. Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK

    Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024 NCT05266846

    Pembrolizumab injection

    Stage IV ALK-rearranged Lung Adenocarcinoma Persistent with 5'ALK Failed from first line Alectinib

    Status may be outdated, last updated 2024-05-30ALK Gene Mutation, Lung Adenocarcinoma, Immunotherapy

77. Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma

    Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China Started 2024 NCT06528847

    Benmelstobart

    …19 deletions, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutations) or ALK rearrangements;

    Status may be outdated, last updated 2024-07-31Non-Small Cell Lung Cancer

78. Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial

    Not yet recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China Started 2024 NCT06282536

    Iruplinalkib

    …f NSCLC by needle biopsy, and evaluated by researchers as stage III-IVA, and diagnosed as ALK positive through genetic testing.

    Status may be outdated, last updated 2024-02-28Potentially Resectable ALK Positive Non-Small Cell Lung Cancer

79. Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

    Recruiting Phase 2 Sun Yat-sen University Started 2024 NCT06563999

    SunvozertinibCrizotinib FDA EUPralsetinibLarotrectinibSavolitinibPyrotinib

    …0ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK fusion.

    Lung Cancer Stage III, Mutation

80. Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

    Recruiting Phase 1/2 Joshua Palmer Started 2024 NCT05987644

    Alectinib FDA EU

    Confirmation of positive ALK rearrangement per local standard of care testing.

    Lung Cancer, NSCLC, Brain Metastases

81. A Study of Avutometinib and Defactinib in People With Thyroid Cancer

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2023 NCT06007924

    AvutometinibDefactinib

    …g genetic alterations: RAS mutation, NF1 mutation, RET rearrangement, NTRK rearrangement, ALK rearrangement, Class 2 or 3 BRAF alterations (non-V600E/K mutations or rearrangements).

    Thyroid Cancer

82. Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative

    Active, not recruiting Phase 2 Qian Chu Started 2023 NCT06001151

    CadonilimabPemetrexedCarboplatin

    Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion

    Carcinoma, Non-Small-Cell Lung

83. Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer

    Recruiting Phase 2 Pingping Song Started 2023 NCT05765877

    WX-0593 Tablets

    ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on…

    Non-Small Cell Lung Cancer(NSCLC)

84. TTI-622 in Combination With Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

    Active, not recruiting Phase 2 Mayo Clinic Started 2023 NCT05507541

    OntorpaceptPembrolizumabMaplirpacept

    ALK positive large B-cell lymphoma

    Recurrent ALK Positive Large B-Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

85. TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 2 Shenzhen TargetRx Started 2023 NCT05955391

    TGRX-326

    With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous …

    Non-small Cell Lung Cancer

86. Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    Recruiting Phase 2 CrystalGenomics Started 2023 NCT05841472

    Camrelizumab (SHR-1210), Pemetrexed, and Carboplatin

    Subject cannot be randomized before receiving the source document for EGFR mutation and ALK translocation.

    Status may be outdated, last updated 2023-08-30Non Squamous Non Small Cell Lung Cancer

87. Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2023 NCT06092086

    Loratinib

    Diagnosed as ALK-positive NSCLC as in CC cohort, but not fulfilled CC cohort inclusion criteria 2\~9 as above menti…

    Status may be outdated, last updated 2023-10-23ALK Positive Non-small Cell Lung Cancer

88. Induction Lorlatinib in Stage III Non-small Cell Lung Cancer

    Active, not recruiting Phase 2 Guangdong Provincial People's Hospital Started 2023 NCT05740943

    Lorlatinib FDA EU

    Pathologically confirmed diagnosis with Stage III NSCLC which harbored ALK fusion detected by next generation sequencing (NGS) or immunohistochemistry (IHC) with or withou…

    Stage III NSCLC, Surgery

89. A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

    Active, not recruiting Phase 1/2 Bristol Myers Squibb Started 2023 NCT06035497

    BMS-986369

    iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).

    Relapsed or Refractory T-cell Lymphomas

90. Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations

    Active, not recruiting Phase 1/2 University of Colorado, Denver Started 2023 NCT05845671

    Amivantamab 1050mgAmivantamab 1400mgAmivantamab (to be determined)Amivantamab (to be determined)

    ALK fusions - alectinib, brigatinib, lorlatinib

    Lung Cancer, Non Small Cell Lung Cancer

91. XTX301 in Patients With Advanced Solid Tumors

    Recruiting Phase 1/2 Xilio Development Started 2023 NCT05684965

    XTX301

    ROS1 fusion, NTRK fusion, BRAF V600E mutation, EGFR mutation, or ALK fusion) must have been previously treated with relevant targeted therapy per local and instituti…

    Advanced Solid Tumor

92. A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

    Recruiting Phase 1/2 AP Biosciences Started 2023 NCT05473156

    AP203AP203

    …ensitive epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement.

    Locally Advanced or Metastatic Solid Tumors, Non Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Esophageal Squamous Cell Carcinoma (ESCC)

93. A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma

    Recruiting Phase 2 Jennifer Crombie, MD Started 2023 NCT05800366

    GlofitamabPolatuzumabRituximabDoxorubicin HydrochlorideCyclophosphamidePrednisone

    ALK-positive large B-cell lymphoma

    Lymphoma, Lymphoma, Large B-Cell, Diffuse

94. The Efficacy and Safety of IBI363 in Solid Tumors

    Recruiting Phase 1/2 Hunan Province Tumor Hospital Started 2023 NCT06081907

    IBI363IBI363IBI363IBI363IBI363

    …ly confirmed advanced NSCLC, who have undergone NGS testing confirming the presence of an ALK fusion mutation and have previously failed standard treatment.

    Status may be outdated, last updated 2024-05-30Advanced Solid Tumor

95. A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer

    Active, not recruiting Phase 1/2 Memorial Sloan Kettering Cancer Center Started 2023 NCT06007937

    Lorlatinib FDA EURamucirumab

    ALK fusion identified by next generation sequencing (NGS) or IHC on material obtained from tumor or …

    Non Small Cell Lung Cancer, Metastatic, Recurrent

96. A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)

    Active, not recruiting Phase 2 Takeda Started 2023 NCT05673785

    Brentuximab VedotinCyclophosphamideDoxorubicinPrednisone

    ALK-positive systemic anaplastic large cell lymphoma (sALCL) with an International Prognostic Index (I…

    Lymphoma

97. A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

    Recruiting Phase 1/2 Nuvalent Started 2022 NCT05384626

    Neladalkib (NVL-655)MidazolamRepaglinideItraconazole

    …y or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.

    Locally Advanced Solid Tumor, Metastatic Solid Tumor

98. Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

    Recruiting Phase 1/2 Aulos Bioscience Started 2022 NCT05267626

    AU-007AldesleukinAvelumabNivolumab

    … (tumor proportion score \[TPS\] ≥ 1%) NSCLC not harboring an activating EGFR mutation or ALK rearrangement and has progressed during or following treatment with an anti-PDx with or without platinu…

    Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer

99. SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

    Recruiting Phase 2 Kelun-Biotech Started 2022 NCT05351788

    SKB264KL-A167CarboplatinCisplatin

    …atients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.

    Non-small Cell Lung Cancer

100. Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

     Active, not recruiting Phase 2 Li Zhang, MD Started 2022 NCT05003037

     Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin

     ALK fusion-positive patients: Progression or intolerance on first-line therapy for ALK fusion-positi…

     Non Small Cell Lung Cancer

101. Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

     Recruiting Phase 2 Hebei Medical University Fourth Hospital Started 2022 NCT05241028

     Ensartinib FDA

     Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS).

     Status may be outdated, last updated 2023-10-10Non-small Cell Lung Cancer

102. A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer

     Not yet recruiting Phase 2 Sichuan University Started 2022 NCT05186506

     Ensatinibchemotherapy

     Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS

     Status may be outdated, last updated 2022-01-11ALK Fusion Protein Expression, Adjuvant Therapy, Non-Small Cell Lung Cancer

103. Alectinib Pharmacokinetic in Patients With NSCLC

     Recruiting Phase 1/2 Instituto Nacional de Cancerologia de Mexico Started 2022 NCT05713006

     Alectinib Oral Product FDA EU

     ALK rearrangements tested by FDA-approved tests (IHQ or FISH)

     Non-small Cell Lung Cancer Stage IIIB, ALK Gene Mutation

104. Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

     Active, not recruiting Phase 2 Intergroupe Francophone de Cancerologie Thoracique Started 2022 NCT05200481

     Brigatinib 180 MG FDA EUCarboplatinPemetrexed

     …udy of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

     Non Small Cell Lung Cancer, ALK Gene Mutation

105. Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation

     Active, not recruiting Phase 2 Sun Yat-sen University Started 2022 NCT05491811

     Ensartinib FDABevacizumab

     ALK positive with TP53 mutation was confirmed by tissue samples or blood in each center

     Non-Small Cell Lung Cancer

106. Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

     Recruiting Phase 1/2 Princess Maxima Center for Pediatric Oncology Started 2022 NCT04925609

     Brigatinib FDA EU

     Patients are required to provide prior results showing an activating ALK aberration in the tumor per local laboratory results, and material needs to be available for central…

     Anaplastic Large Cell Lymphoma, ALK-Positive, Inflammatory Myofibroblastic Tumor, Other Solid Tumor

107. A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

     Active, not recruiting Phase 1/2 Roche Started 2021 NCT04774718

     Alectinib FDA EU

     Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the investigational F1CDx assay or based on pre-…

     ALK Fusion-positive Solid or CNS Tumors

108. The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer

     Active, not recruiting Phase 2 Yale University Started 2021 NCT04699123

     NC318 800 mgNC318 400 mgPembrolizumab

     Patients with NSCLC known to harbor an ALK rearrangement, ROS1 rearrangement, EGFR mutation or BRAF mutation known to be sensitive to FDA approved…

     Advanced Non-small Cell Lung Cancer

109. Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

     Active, not recruiting Phase 2 Daiichi Sankyo Started 2021 NCT04703192

     Valemetostat Tosylate

     Anaplastic large cell lymphoma, ALK positive

     Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma

110. Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)

     Active, not recruiting Phase 2 University Hospital Southampton NHS Foundation Trust Started 2021 NCT04546620

     R-CHOPR-CHOP + acalabrutinib

     ALK-positive large B-cell lymphoma

     Diffuse Large B Cell Lymphoma

111. The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.

     Recruiting Phase 2 Hunan Province Tumor Hospital Started 2021 NCT04777084

     IBI318

     …ancer, TNM Lung cancer stage 8) with histologically confirmed EGFR-sensitive mutations or ALK fusion, Relapse after failure of anti-EGFR-TKI or ALK-TKI therapy, as follows:

     Non-Small Cell Lung Cancer

112. Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

     Active, not recruiting Phase 2 Gruppo Oncologico Italiano di Ricerca Clinica Started 2021 NCT05015010

     Alectinib FDA EU

     Documented ALK-positive disease according to an FDA-approved and CE-marked test.

     Status may be outdated, last updated 2024-08-09Non Small Cell Lung Cancer

113. ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

     Recruiting Phase 2 Hunan Province Tumor Hospital Started 2021 NCT05014464

     Crizotinib FDA EU

     ALK fusion positive evaluated by IHC (ventana), NGS or FISH.

     Status may be outdated, last updated 2024-09-20Non-small Cell Lung Cancer

114. Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer

     Active, not recruiting Phase 2 Gustave Roussy, Cancer Campus, Grand Paris Started 2021 NCT04940325

     DS-1062a

     Participants who have known EGFR, BRAF, and MET mutation or ALK, ROS1, RET, NTRK fusion: one line of an approved targeted agent and one platinum-doublet regimen

     Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer, Unresectable Non-small Lung Cancer

115. Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

     Recruiting Phase 2 Iovance Biotherapeutics Started 2021 NCT04614103

     LN-145LN-145

     For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted th…

     Metastatic Non Small Cell Lung Cancer

116. A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

     Recruiting Phase 2 Roche Started 2020 NCT04302025

     Alectinib FDA EUEntrectinibVemurafenibCobimetinibPralsetinibAtezolizumab

     …ts (CLIA)-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1/2/3 fusion

     Non-small Cell Lung Cancer

117. Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)

     Active, not recruiting Phase 2 SWOG Cancer Research Network Started 2020 NCT04268550

     Selpercatinib

     This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping…

     Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

118. Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

     Active, not recruiting Phase 2 Fundación GECP Started 2020 NCT04223596

     Brigatinib FDA EU

     …nal Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, that is ALK+

     Lung Cancer, NSCLC, NSCLC Stage IIIB, NSCLC Stage IV

119. Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

     Active, not recruiting Phase 1/2 University of Washington Started 2020 NCT04231877

     Polatuzumab VedotinRituximabPrednisoneEtoposideDoxorubicinCyclophosphamide

     ALK+ large B-cell lymphoma (must be CD20+)

     Aggressive Non-Hodgkin Lymphoma, ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

120. Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients

     Active, not recruiting Phase 2 European Organisation for Research and Treatment of Cancer - EORTC Started 2020 NCT04127110

     Lorlatinib FDA EU

     Histologically or cytologically confirmed diagnosis of NSCLC with ALK rearrangement, assessed by fluorescence in situ hybridization (FISH) assay (Abbott Molecular Inc) or by…

     Non Small Cell Lung Cancer

121. A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

     Recruiting Phase 2 Centre Leon Berard Started 2020 NCT04116541

     HDM201RibociclibCabozantinibAlectinib FDA EURegorafenibTrametinib

     Cohort Alectinib : Activating ALK alterations: translocation, or selected mutations, or activating rearrangements following validation …

     Malignant Solid Tumor

122. PLATFORM Study of Precision Medicine for Rare Tumors

     Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020 NCT04423185

     Almonertinib 110 MGDacomitinib 45 MGAlectinib 150 MG FDA EUCrizotinib 250 MG FDA EUPyrotinib 160/80 MGImatinib 400 MG

     when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mutation, C-KI…

     Rare Tumor

123. Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

     Active, not recruiting Phase 1/2 BicycleTx Limited Started 2020 NCT04561362

     BT8009Pembrolizumab

     …ns, such as Epidermal Growth Factor Receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion oncogene, or ROS1 that have progressed following prior therapy.

     Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms

124. Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

     Recruiting Phase 2 National Cancer Institute (NCI) Started 2019 NCT04002947

     DA-EPOCHRituximabCHOPAcalabrutinib

     ALK+ large B-cell lymphoma

     Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, NHL

125. Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2)

     Active, not recruiting Phase 2 Gustave Roussy, Cancer Campus, Grand Paris Started 2019 NCT03703050

     Nivolumab cohort 1Nivolumab cohort 2

     Histologically confirmed evidence of relapsed/refractory ALK+ ALCL.

     Relapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma

126. Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas

     Active, not recruiting Phase 1/2 City of Hope Medical Center Started 2019 NCT03598998

     PembrolizumabPralatrexate

     Anaplastic large cell lymphoma, ALK-positive

     Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype, Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma

127. X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

     Active, not recruiting Phase 2 Fudan University Started 2019 NCT03753685

     X-396(Ensartinib) Capsule FDA

     …tologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.

     Nonsmall Cell Lung Cancer, Brain Metastases

128. 1st Line Durvalumab in PS 2 NSCLC Patients

     Active, not recruiting Phase 2 Swiss Cancer Institute Started 2018 NCT03620669

     Durvalumab

     No sensitizing EGFR mutation (L858R or exon 19 deletions), ALK fusion oncogene or rearrangements of the ROS1 gene detected in patients with a non-squamous cell…

     NSCLC Stage IV, NSCLC Stage IIIB

129. Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas

     Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018 NCT03038672

     NivolumabVarlilumab

     ALK+ large B-cell lymphoma

     ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation, Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type

130. Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

     Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018 NCT03213652

     Ensartinib FDA

     … or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

     Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

131. A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC

     Active, not recruiting Phase 1/2 Massachusetts General Hospital Started 2017 NCT03202940

     Alectinib FDA EUCobimetinib

     …tologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved fluorescence in-situ hy…

     Non-small Cell Lung Cancer

132. Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma

     Active, not recruiting Phase 2 City of Hope Medical Center Started 2017 NCT03113500

     Brentuximab VedotinCyclophosphamideDoxorubicinDoxorubicin HydrochlorideEtoposideEtoposide Phosphate

     Anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) with international protein index (IPI) of 2 or high…

     Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Angioimmunoblastic T-Cell Lymphoma

133. Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

     Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2017 NCT02978625

     NivolumabTalimogene Laherparepvec

     … (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL), and NK-cell lymphomas

     Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Apocrine Carcinoma, Carcinoma Arising From Cylindroma

134. A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

     Recruiting Phase 1/2 Bristol Myers Squibb Started 2017 NCT03093116

     Oral repotrectinib (TPX-0005)

     …ng primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.

     Locally Advanced Solid Tumors, Metastatic Solid Tumors

135. Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

     Active, not recruiting Phase 1/2 AIDS Malignancy Consortium Started 2016 NCT02797470

     CarmustineCytarabineEtoposideLentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor CellsMelphalan

     …opsy proven plasmablastic lymphomas, or peripheral T cell lymphoma (with the exception of ALK+ type in first or second complete remission) \*NOTE: Patients meeting the following criter…

     HIV Infection, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Plasmablastic Lymphoma, Recurrent Adult Hodgkin Lymphoma

136. Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

     Active, not recruiting Phase 2 Roche Started 2015 NCT02568267

     Entrectinib

     …agnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

     Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms

137. Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F)

     Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015 NCT04439266

     Crizotinib FDA EU

     Patients must have an ALK rearrangement as defined via the MATCH Master Protocol

     Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma

138. Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)

     Not yet recruiting Phase 1 The Methodist Hospital Research Institute Starts 2027 NCT07729397

     Autologous C7R.CD30-CAR-EBVSTs

     ALK-positive anaplastic T cell lymphoma

     Diffuse Large B-Cell Lymphoma (DLBCL), Hodgkin Lymphoma, Peripheral T-cell Lymphoma (PTCL), Anaplastic Large Cell Lymphoma, ALK-Positive

139. huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers

     Not yet recruiting Phase 1 University of Pennsylvania Starts 2027 NCT07891468

     huCART19-IL18-CD428z cells

     ALK+ Anaplastic Large B-cell Lymphoma

     Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Richter's Transformation

140. Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib

     Recruiting Phase 1 University of Chicago Started 2026 NCT07782359

     Tirzepatide

     Receiving lorlatinib as first-line treatment for advanced NSCLC ALK-positive, already prescribed and administered by the patient's treating oncologist as standard of …

     Lung Cancer

141. Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

     Recruiting Phase 1 Nuvectis Pharma Started 2026 NCT07784959

     NXP900Lorlatinib FDA EU

     Unresectable, metastatic or locally advanced ALK-positive NSCLC.

     ALK Positive, ALK Positive Non-small Cell Lung Cancer, NSCLC, ALK+ Non-Small-Cell Lung Carcinoma

142. CD45BE-HSPC + CART-45 Cells

     Recruiting Phase 1 University of Pennsylvania Started 2026 NCT07451054

     CART-45 cellsCD45BE-HSPC

     ALK+ Anaplastic Large B-cell Lymphoma

     B-Cell Non-Hodgkin Lymphoma (NHL), Richter's Transformation, T-Cell Non-Hodgkin Lymphoma, Hodgkin Lymphoma

143. AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer

     Recruiting Phase 1 Roche Started 2026 NCT07617337

     AQUA07Lorlatinib FDA EU

     …xcluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC, who have experienced disease progression during or following their most recent sys…

     ALK Positive Non-small Cell Lung Cancer

144. A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin Lymphoma

     Recruiting Phase 1 Kyowa Kirin Started 2026 NCT07192471

     KK2223

     CD30+ PTCL must have prior brentuximab vedotin treatment or intolerance, and/or ALK-positive ALCL participants should have previously received crizotinib if indicated (crizotinib adm…

     T-cell NHL (PTCL or CTCL)

145. OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy

     Recruiting Phase 1 M.D. Anderson Cancer Center Started 2026 NCT07655583

     L858R) NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged/fusion positive NSCLC.

     Brain Metastasis, Stereotactic Radiosurgery, Resection, Systemic Therapy

146. A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)

     Recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2025 NCT07001384

     Alectinib FDA EUDuvelisib

     Pathologically-confirmed diagnosis of ALK+ ALCL by WHO/ICC, classification procedures in use at the time of diagnosis.

     Anaplastic Lymphoma Kinase, Anaplastic Large Cell Lymphoma

147. Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas

     Recruiting Phase 1 Baylor College of Medicine Started 2025 NCT06176690

     C7R.CD30.CAR-EBVST cells

     ALK-positive anaplastic T cell lymphoma

     CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, Anaplastic Large Cell Lymphoma, ALK-Positive, Peripheral T-cell Lymphoma

148. A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies

     Recruiting Phase 1 Shanghai Junshi Bioscience Started 2025 NCT06839105

     TaxolCisplatin or CarboplatinPemetrexedOxaliplatinCapecitabineBevacizumab

     Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase inhibitors.

     Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor

149. A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

     Recruiting Phase 1 Astellas Started 2025 NCT07140016

     gilteritinib

     …tastatic non-small cell lung cancer (NSCLC) with a documented anaplastic lymphoma kinase (ALK) rearrangement and is not amenable to curative intent treatment.

     Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive

150. Gilteritinib for the Treatment of ALK NSCLC

     Recruiting Phase 1 University of Michigan Rogel Cancer Center Started 2024 NCT06225427

     Gilteritinib

     …nt Committee on Cancer \[AJCC\] 8th edition) non-small cell lung cancer with an oncogenic ALK fusion

     Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

151. A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma

     Active, not recruiting Phase 1 Treeline Biosciences Started 2024 NCT06733441

     TLN-254TLN-254

     Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive.

     Lymphoma

152. A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

     Recruiting Phase 1 CSPC Started 2024 NCT07110883

     SYS6023

     …ipants, and Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) fusion, ROS Proto-Oncogene 1, receptor tyrosine kinase (ROS1) fusion, B-Raf Proto-Oncogene, seri…

     Advanced Solid Tumor

153. APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST

     Recruiting Phase 1 Ascentage Pharma Group Started 2024 NCT06687070

     APG -2449PLD

     Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.

     Platinum-resistant Recurrent Ovarian Cancer, Advanced Solid Tumor

154. A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors

     Recruiting Phase 1 Chongqing Precision Biotech Started 2023 NCT06043466

     CEA-targeted CAR-T cells

     For patients with positive ALK fusion and drug resistance after first-line crizotinib treatment, second-line treatment with cer…

     Status may be outdated, last updated 2023-09-21Colorectal Cancer, Esophagus Cancer, Gastric Cancer, Pancreas Cancer

155. Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

     Active, not recruiting Phase 1 AbbVie Started 2023 NCT05753501

     ABBV-101Venetoclax

     …-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrang…

     Hematologic Cancer

156. TmCD19-IL18 in CD19+ Cancers

     Active, not recruiting Phase 1 University of Pennsylvania Started 2023 NCT05989204

     TmCD19-IL18

     ALK+ Anaplastic Large B-cell Lymphoma

     Non Hodgkin Lymphoma

157. Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

     Recruiting Phase 1 BioNTech Started 2022 NCT05142189

     BNT116CemiplimabDocetaxelCarboplatinPaclitaxelBNT316

     Participants' NSCLC must have ALK rearrangement or RET rearrangement.

     Non-Small Cell Lung Cancer

158. Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer

     Active, not recruiting Phase 1 M.D. Anderson Cancer Center Started 2021 NCT04837716

     BevacizumabCarboplatinEnsartinib FDAPemetrexed

     …arboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer

     Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

159. huCART19-IL18 in CD19+ Cancers

     Active, not recruiting Phase 1 University of Pennsylvania Started 2021 NCT04684563

     huCART19-IL18

     ALK+ Anaplastic Large B-cell Lymphoma

     Chronic Lymphocytic Leukemia, Non-hodgkin Lymphoma, Acute Lymphoblastic Leukemia

160. TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC)

     Active, not recruiting Phase 1 Shenzhen TargetRx Started 2021 NCT05441956

     TGRX-326

     Diagnosis of ALK-positive or ROS1-positive advanced NSCLC by histopathology or cytology in a Grade-A tertiary hospi…

     Non-small Cell Lung Cancer

161. Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas

     Active, not recruiting Phase 1 Baylor College of Medicine Started 2020 NCT04288726

     CD30.CAR-EBVST cells

     ALK-positive anaplastic T cell lymphoma

     Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type, Classical Hodgkin Lymphoma

162. Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC

     Active, not recruiting Phase 1 City of Hope Medical Center Started 2020 NCT04227028

     BevacizumabBrigatinib FDA EU

     …ither primary or metastatic site) diagnosis of locally advanced, recurrent, or metastatic ALK rearranged non-small cell lung cancer (NSCLC)

     Locally Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8

163. Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

     Recruiting Phase 1 UNC Lineberger Comprehensive Cancer Center Started 2020 NCT04223765

     CAR.k.28FludarabineCyclophosphamideBendamustine

     ALK-positive large B-cell lymphoma

     Mantle Cell Lymphoma, Follicular Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue

164. APG-2449 in Patients With Advanced Solid Tumors

     Recruiting Phase 1 Ascentage Pharma Group Started 2019 NCT03917043

     APG-2449

     …stage: non-small cell lung cancer diagnosed by histology and/or cytology and positive for ALK/ROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, e…

     Advanced Solid Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer

165. CCL21-Gene Modified Dendritic Cell Vaccine and Pembrolizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer

     Active, not recruiting Phase 1 Jonsson Comprehensive Cancer Center Started 2019 NCT03546361

     Autologous Dendritic Cell-Adenovirus CCL21 VaccinePembrolizumab

     …ior tyrosine kinase inhibitor therapy in patients with a sensitizing EGFR mutation and/or ALK gene rearrangement.

     Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

166. Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma

     Active, not recruiting Phase 1 UNC Lineberger Comprehensive Cancer Center Started 2019 NCT03696784

     iC9-CAR19 T cellsBendamustineFludarabineAP1903Cyclophosphamide

     ALK-positive large B-cell lymphoma

     Lymphoma, Lymphoma, B-Cell, Immune System Diseases, Immunoproliferative Disorders

167. Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

     Active, not recruiting Phase 1 M.D. Anderson Cancer Center Started 2018 NCT03707938

     Brigatinib FDA EU

     …l of Local Consolidative Therapy (LCT) With Brigatinib in Tyrosine Kinase Inhibitor-Naive ALK-Rearranged Advanced NSCLC

     Advanced Lung Carcinoma, ALK Gene Rearrangement, Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma

168. Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

     Active, not recruiting Phase 1 M.D. Anderson Cancer Center Started 2016 NCT02321501

     Ceritinib FDA EUEverolimus

     For dose expansion cohort: patients with stage IIIB or IV ALK + NSCLC who have failed at least one line of therapy and are progressing on an ALK inhibito…

     ALK Positive, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, ROS1 Gene Rearrangement

169. Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

     Active, not recruiting Phase 1 Novartis Started 2015 NCT02393625

     Ceritinib (LDK378) FDA EUNivolumab

     Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement

     ALK-positive NSCLC

170. An Open-label, Single-arm, Multicenter Phase II Clinical Study of Azacitidine, Chidamide Combined With PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma.

     Recruiting Early Phase 1 Second Affiliated Hospital of Soochow University Started 2026 NCT07598578

     Azacitidine (AZA)

     anaplastic large cell lymphoma (ALK-negative or ALK-positive)

     Peripheral T-Cell Lymphoma Refractory

171. A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors

     Recruiting Early Phase 1 Henlius Started 2025 NCT07274813

     HLX37

     …squamous NSCLC subjects, there must be previous test results confirming negative EGFR and ALK gene alterations.

     Advanced/Metastatic Solid Tumors, NSCLC

172. Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

     Recruiting Early Phase 1 Nationwide Children's Hospital Started 2025 NCT06333899

     Lorlatinib FDA EULorlatinib with chemotherapy1 FDA EULorlatinib with chemotherapy 2 FDA EULorlatinib post Radiation FDA EU

     Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

     High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Infant Type Hemispheric Glioma

173. Neoadjuvant Iruplinalkib and Bevacizumab in ALK-positive NSCLC: A Phase II Single-arm Trial

     Not yet recruiting No phase Shanghai Pulmonary Hospital, Shanghai, China Started 2026 NCT07870733

     Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:

     Stage II-III NSCLC per investigator, and ALK-positive.

     ALK, NSCLC, Neoadjuvant Therapy

174. Anti CD19 Gene Therapy for B-cell Lymphoma

     Recruiting No phase Anhui Provincial Hospital Started 2026 NCT07211048

     Anti-CD19 gene injection

     ALK-positive anaplastic large B-cell lymphoma

     B-cell Lymphoma

175. Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context

     Recruiting No phase Pfizer Started 2025 NCT06487078

     Lorlatinib FDA EU

     …ologically confirmed diagnosis of locally advanced or metastatic (TNM 8th classification) ALK-positive NSCLC (IHC 3+/FISH positive/transcriptomic method)

     ALK+ Non-Small-Cell Lung Carcinoma

176. Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)

     Recruiting No phase Karolinska University Hospital Started 2023 NCT05724004

     ALK-rearrangement

     Status may be outdated, last updated 2023-10-10Radiotherapy Side Effect, Non-small Cell Lung Cancer, ALK Gene Mutation

177. Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC

     Recruiting No phase Groupe Francais De Pneumo-Cancerologie Started 2021 NCT05122806

     RNAseq

     ALK rearrangement confirmed by IHC and/or FISH or NGS according to local methods

     Non-small Cell Lung Cancer, ALK Gene Rearrangement Positive

178. Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

     Active, not recruiting No phase National Cancer Institute (NCI) Started 2014 NCT02194738

     CarboplatinCisplatinCrizotinib FDA EUErlotinibGemcitabine HydrochlorideNivolumab

     No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4

     Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8

179. Screening With Whole Body MRI For Detection Of Primary Tumors In Children And Adults With Li-Fraumeni Syndrome (LFS) And Other Cancer Predisposition Syndromes

     Active, not recruiting No phase Dana-Farber Cancer Institute Started 2012 NCT02950987

     Familial Neuroblastoma with a germline ALK mutation

     Li-Fraumeni Syndrome

180. Global, Multicenter Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

     Recruiting Phase 2/3 Multitude Therapeutics Started 2026 NCT07718737

     AMT-116

     6.2 Patients with gene mutations that do not routinely use immunotherapy (e.g., ALK fusion): Have experienced disease progression after targeted therapy for gene mutations and plat…

     Broad match: ALK fusionNSCLC (Advanced Non-small Cell Lung Cancer)

181. A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)

     Recruiting Phase 3 Pfizer Started 2025 NCT07144280

     PF-08046054Docetaxel monotherapy

     Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:

     Broad match: ALK fusionNon-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Carcinoma

182. A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

     Active, not recruiting Phase 3 Genmab Started 2023 NCT05578976

     EpcoritamabCyclophosphamideRituximabVincristineDoxorubicinPrednisone

     plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymph…

     Broad match: ALK fusionDiffuse Large B-Cell Lymphoma

183. Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease

     Not yet recruiting Phase 1/2 National University Hospital, Singapore Started 2026 NCT07681297

     Tislelizumab + Bevacizumab + Capecitabine

     Patients with driver mutations (e.g., EGFR-mutant or ALK-rearranged NSCLC, HER2+ metastatic breast cancer) must have received at least one prior line of matc…

     Broad match: ALK fusionAdvanced Solid Tumor Cancer, Triple-Negative Breast Cancer (TNBC), CNS Disease, Breast Cancer

184. DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

     Recruiting Phase 2 DualityBio Started 2025 NCT06953089

     DB-1311/BNT324BNT327DB-1305/BNT325

     Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations

     Broad match: ALK fusionSolid Tumors

185. Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma

     Recruiting Phase 1/2 Chia Tai Tianqing Started 2025 NCT06829771

     TQB2825 injection +R-CHOP regimenTQB2825 injection + GemOx

     …uman herpesvirus 8 (HHV8)-positive/primary effusion lymphoma, Anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma, Burkitt's lymphoma, and Hodgkin's lymphoma, etc.);

     Broad match: ALK fusionDiffuse Large B Cell Lymphoma

186. A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer

     Not yet recruiting Phase 2 CSPC Started 2024 NCT06525350

     Glumetinib tabletsHB1801 (docetaxel, albumin-bound）Docetaxel

     Driver genes alterations must be negative (including EGFR mutations, ALK fusion, ROS1 rearrangement fusion, BRAF V600 mutation, NTRK fusion, MET 14 exon skipping mutatio…

     Broad match: ALK fusionStatus may be outdated, last updated 2024-07-29Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression

187. Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases

     Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024 NCT06440954

     Intrathecal pemetrexed

     EGFR mutant, ALK fusion, ROS1 fusion, and other oncogenic alterations including RET fusion, BRAF mutation, NTRK f…

     Broad match: ALK fusionStatus may be outdated, last updated 2024-06-04Non-Small Cell Lung Cancer

188. Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma

     Recruiting Phase 1/2 Haihe Biopharma Started 2022 NCT06909877

     HH2853 Tablets

     …must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL), monomorphic epithel…

     Broad match: ALK fusionRelapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

189. Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 mAb, Administered Alone and in Combination With a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study)

     Recruiting Phase 1/2 Phanes Therapeutics Started 2022 NCT05431270

     Mavrostobart (PT199)TislelizumabGemcitabine + nab-PaclitaxelDocetaxelPemetrexedGemcitabine

     …onfirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations and radiological documentation of disease progression on prior treatments, which may inc…

     Broad match: ALK fusionNon Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma

190. RAPA-201 Therapy of Solid Tumors

     Recruiting Phase 1/2 Rapa Therapeutics Started 2021 NCT05144698

     RAPA-201 Rapamycin Resistant T CellsChemotherapy Prior to RAPA-201 TherapyPembrolizumab (PD-1 Blocking Antibody)

     …c alterations and mutations (including but not limited to BRAF, BRCA, EGFR mutations, and ALK translocations) must have either received targeted therapy for such conditions or provided written docum…

     Broad match: ALK fusionSolid Tumor, Small Cell and Non-small Cell Lung Cancer, Head and Neck Cancer, Squamous Cell Carcinoma of Oral Cavity

191. JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

     Recruiting Phase 1 Jecho Biopharmaceuticals Started 2026 NCT07603479

     JL19001, subcutaneous injection, 1 μg/kgJL19001, subcutaneous injection, 5 μg/kgJL19001, subcutaneous injection,10 μg/kgJL19001, subcutaneous injection,15 μg/kgJL19001, subcutaneous injection,20 μg/kgJL19001, subcutaneous injection,25 μg/kg

     For patients with driver alterations (e.g., EGFRmutations, ALKfusions, ROS1fusions, BRAF V600mutations, NTRKfusions, METexon 14 skipping, RETalterations, KRAS …

     Broad match: ALK fusionMalignancies, Solid Malignant Tumor, NHL (Non-Hodgkin Lymphoma), Solid Tumor Cancer

192. Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC

     Recruiting No phase Kong Fanming Started 2025 NCT07086300

     …lecular biological methods, to exclude common driver mutations such as EGFR mutations and ALK rearrangements.

     Broad match: ALK fusionElderly Patients (>65 Years), Non-Small Cell Lung Cancer, PD-1 Inhibitors, Electroacupuncture