EGFR exon 20 insertion

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.

Companion diagnostic tests

Tests the FDA has approved to select patients for a specific therapy. Other validated tests are often used in practice, especially in Europe.

Drugs in active trials

Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.

25 of 35 drugs shown

Show all 35 drugs

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.

Companies

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

1. Dizal Pharmaceuticals 4
2. Johnson & Johnson 4
3. Avistone Biotechnology 3
4. Taiho Pharmaceutical 3
5. ArriVent BioPharma 2
6. BeBetter Med 2
7. ORIC Pharmaceuticals 2
8. Takeda 2
9. AstraZeneca 1
10. Dizal (Jiangsu) Pharmaceutical 1
11. Shanghai JMT-Bio 1
12. Suzhou Puhe Pharmaceutical Technology 1
13. Baili-Bio / SystImmune 1
14. Allist Pharmaceuticals 1
15. Beijing Pearl Biotechnology 1

Phase 1 Phase 2 Phase 3 Phase 4 No phase

Trials

Matched automatically from registry text, so a few trials may only mention EGFR exon 20 insertion rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

53 of 81 trials shown

1. A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens

   Not yet recruiting Phase 4 Shanghai Pulmonary Hospital, Shanghai Started 2026Primary completion 2029-08 NCT07469488

   Enhanced dermatologic managementEnhanced IRR ProphylaxisEnhanced VTE Prophylaxis (Cohort 1 only)

   Cohort 3 (EGFR Ex20ins 1L):

   NSCLC (Advanced Non-small Cell Lung Cancer), VTE (Venous Thromboembolism), Rash Due to Epidermal Growth Factor Receptor Inhibitors, Infusion Reaction

2. A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery

   Recruiting Phase 3 Dizal (Jiangsu) Pharmaceutical Started 2025Primary completion 2029-09 NCT07182682

   sunvozertinib FDAMatching Placebo

   Have documented EGFR exon20ins (Cohort 1) or EGFR PACC mutations (Cohort 2) from a local Clinical Laboratory Improvement…

   Non-Small Cell Lung Cancer

3. A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

   Recruiting Phase 3 Taiho Pharmaceutical Started 2025Primary completion 2029-10 NCT07128199

   zipalertinib

   1. exon20 insertion mutations (ex20ins) or

   Lung Cancer, Adjuvant, Post-surgical, EGFR

4. JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations

   Not yet recruiting Phase 3 Shanghai JMT-Bio Started 2024Primary completion 2027-03 NCT06380348

   JMT101osimertinibcisplatinpemetrexed

   For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample.

   Status may be outdated, last updated 2024-04-23Local Advanced or Metastatic NSCLC

5. Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

   Active, not recruiting Phase 3 ArriVent BioPharma Started 2023Primary completion 2025-08 NCT05607550

   furmonertinibplatinum-based chemotherapy

   Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.

   Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations

6. YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

   Not yet recruiting Phase 3 Suzhou Puhe Pharmaceutical Technology Started 2023Primary completion 2025-07 NCT05767892

   YK-209A tabletpemetrexedcarboplatincisplatin

   Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (China…

   Status may be outdated, last updated 2023-04-05Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

7. Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.

   Enrolling by invitation Phase 3 Avistone Biotechnology Started 2023Primary completion 2028-06 NCT06281964

   PLB1004pemetrexedcarboplatincisplatinsintilimab

   Tumor tissue is positive for EGFR Ex20ins as documentally confirmed by next-generation sequencing (NGS) testing or written confirma…

   Non-Small-Cell Lung Cancer

8. REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

   Active, not recruiting Phase 3 Taiho Pharmaceutical Started 2023Primary completion 2027-05 NCT05973773

   zipalertinib

   Prior therapy with EGFR TKI agents targeting exon20ins mutations including amivantamab, mobocertinib, sunvozertinib, furmonertinib, and poziotin…

   Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation

9. SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

   Active, not recruiting Phase 2/3 Baili-Bio / SystImmune Started 2022Primary completion 2025-12 NCT05020769

   SI-B001osimertinib

   …all cell lung cancer (NSCLC) confirmed by histopathology and/or cytology, T790M-negative, Exon20ins mutation resistant to the third generation EGFR TKI after the first or second line treatm…

   Non-small Cell Lung Cancer

10. A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

    Active, not recruiting Phase 3 Dizal Pharmaceuticals Started 2022Primary completion 2026-01 NCT05668988

    sunvozertinib FDApemetrexedcarboplatin

    Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation

    Non-small Cell Lung Cancer

11. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

    Active, not recruiting Phase 3 Johnson & Johnson Started 2020Primary completion 2023-05 NCT04538664

    amivantamab FDA EUpemetrexedcarboplatin

    … cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation

    Carcinoma, Non-Small-Cell Lung

12. Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Jonsson Comprehensive Cancer Center Starts 2027Primary completion 2029-06 NCT07229339

    carboplatinpemetrexedzipalertinib

    …tologically confirmed non-squamous NSCLC performed within 90 days of enrollment with EGFR Ex20Ins-mutated (addition of 1 or more amino acids) or uncommon/compound EGFR mutations (E709X, G…

    Lung Non-Squamous Non-Small Cell Carcinoma

13. High-Dose Firmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed in the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

    Not yet recruiting Phase 2 Qiming Wang Started 2025Primary completion 2027-01 NCT06971406

    Combination therapy prospective cohort

    EGFR mutations confirmed by genetic testing (EGFR Ex19del/L858R/Ex20ins/PACC/L861Q).

    Non Small Cell Lung Cancer, EGFR Mutation, Leptomeningeal Metastases, Targeted Therapy

14. Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.

    Recruiting Phase 2 Fondazione Ricerca Traslazionale Started 2025Primary completion 2027-10 NCT07392658

    amivantamab FDA EU

    …ically or cytologically confirmed stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation;

    Metastatic NSCLC - Non-Small Cell Lung Cancer

15. Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC

    Recruiting Phase 2 Tang-Du Hospital Started 2025Primary completion 2026-12 NCT06864624

    sunvozertinib FDA

    EGFR exon 20 insertion mutation confirmed by an approved local laboratory.

    NSCLC

16. Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations

    Recruiting Phase 2 BeBetter Med Started 2024Primary completion 2027-06 NCT06514027

    BEBT-109 Capsulespemetrexedcarboplatincisplatin

    EGFR exon 20 insertion mutations confirmed by peripheral blood or tumor tissue testing conducted by a tertiary h…

    Non Small Cell Lung Cancer

17. Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

    Active, not recruiting Phase 2 Guangdong Provincial People's Hospital Started 2024Primary completion 2026-01 NCT06300424

    aumolertinibcarboplatinnab-paclitaxel

    6. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q

    Non Small Cell Lung Cancer, EGFR Gene Mutation

18. A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

    Recruiting Phase 1/2 Yuhan Started 2024Primary completion 2028-03 NCT06616766

    YH42946

    Documented HER2 aberration or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)

    NSCLC (Non-small Cell Lung Cancer), Solid Tumor

19. Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC

    Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2024Primary completion 2027-06 NCT06863506

    befotertinib

    Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion)

    NSCLC (Non-small Cell Lung Cancer)

20. Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.

    Active, not recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2024Primary completion 2030-05 NCT07274761

    sunvozertinib FDA

    4.Confirmed EGFR exon 20 insertion mutation by a validated test. 5.No evidence of disease progression within the past two we…

    Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer

21. A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

    Recruiting Phase 2 Taiho Pharmaceutical Started 2023Primary completion 2028-08 NCT05967689

    zipalertinibCYP CocktailTransporter Cocktail

    Progressed on or after systemic therapy with an agent targeting ex20ins, either alone or in combination with standard platinum-based chemotherapy for the treatme…

    Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

22. A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

    Recruiting Phase 1/2 D3 Bio Started 2023Primary completion 2028-08 NCT05886920

    D3S-002D3S-001

    …to EGFR Exon19 Deletions, Exon21 p.L858R, Exon21 p.L861Q, Exon18 p.G719X, Exon20 p.S768I, Exon20 Insertions, Exon20 p.T790M.

    Advanced Solid Tumors With MAPK Pathway Mutations

23. A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)

    Active, not recruiting Phase 2 Avistone Biotechnology Started 2023Primary completion 2025-03 NCT06015503

    PLB1004

    Participants with EGFR ex20ins mutation.

    NSCLC (Non-small Cell Lung Cancer)

24. Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer

    Recruiting Phase 2 BeBetter Med Started 2022Primary completion 2025-12 NCT06706713

    BEBT-109 Capsule

    Written test reports confirm the occurrence of EGFR exon 20 insertion mutations.

    Non-Small Cell Lung Cancer, EGFR Exon 20 Insertion Mutation

25. Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion

    Active, not recruiting Phase 2 Allist Pharmaceuticals Started 2022Primary completion 2025-06 NCT05466149

    furmonertinib

    …as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation

    NSCLC

26. Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

    Recruiting Phase 1/2 ORIC Pharmaceuticals Started 2022Primary completion 2026-09 NCT05315700

    ORIC-114carboplatinpemetrexed

    EGFR exon 20 insertion mutation

    Solid Tumors

27. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

    Recruiting Phase 2 Johnson & Johnson Started 2022Primary completion 2027-08 NCT05498428

    amivantamab FDA EUlazertinibcarboplatinpemetrexedDirect Oral Anticoagulant (DOAC)Low Molecular Weight Heparin (LMWH)

    Cohort 2: EGFR Exon 20ins mutation.

    Carcinoma, Non-small-Cell Lung

28. Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

    Recruiting Phase 1/2 Betta Pharmaceuticals Started 2021Primary completion 2028-04 NCT04930432

    MCLA-129

    Cohort B: Advanced NSCLC patients diagnosed with EGFR exon 20 insertion mutation (Exon20ins).

    Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Cancer

29. Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)

    Active, not recruiting Phase 2 Dizal Pharmaceuticals Started 2021Primary completion 2022-10 NCT05712902

    sunvozertinib FDA

    Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories or sponsor-designated central laborat…

    Non-Small Cell Lung Cancer

30. A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Cullinan Therapeutics Started 2019Primary completion 2025-10 NCT04036682

    zipalertinib

    Documented EGFR ex20ins mutation demonstrated by a validated test listed in Section 9.7 and performed in a Clinic…

    Non Small Cell Lung Cancer, EGFR Exon 20 Mutation

31. Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

    Active, not recruiting Phase 1/2 Dizal Pharmaceuticals Started 2019Primary completion 2024-07 NCT03974022

    sunvozertinib FDA

    Part A Dose expansion: Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins, who have not received prior systemic therapy (treatment naïve).

    Non-Small Cell Lung Cancer

32. Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2027-06 NCT03191149

    osimertinib

    An EGFR exon 20 insertion mutation must be detected in the tumor tissue.

    Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7

33. A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Takeda Started 2016Primary completion 2026-10 NCT02716116

    mobocertinib

    Have a documented EGFR in-frame exon 20 insertion by a local test.

    Carcinoma, Non-Small-Cell Lung

34. ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

    Recruiting Phase 1 ORIC Pharmaceuticals Started 2025Primary completion 2026-12 NCT06816992

    ORIC-114amivantamab FDA EU

    Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method

    Solid Tumors, EGFR Exon 20 Insertion Mutations, NSCLC, EGFR-mutated NSCLC

35. A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

    Active, not recruiting Phase 1 Kumquat Biosciences Started 2024Primary completion 2026-12 NCT06507306

    KQB198osimertinibamivantamab FDA EU

    Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation

    Solid Tumor, Adult

36. A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Abbisko Therapeutics Started 2024Primary completion 2027-03 NCT06225804

    ABSK112

    For the expansion part, patients have documented EGFR in-frame exon 20 insertion mutations confirmed by certificated local laboratories

    Non-Small Cell Lung Cancer

37. A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors

    Not yet recruiting Phase 1 Hansoh Pharma Started 2023Primary completion 2025-07 NCT05940116

    HS-20117

    … A: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR exon 20ins mutations who have progressed after prior platinum-based chemotherapy or are intolerant t…

    Status may be outdated, last updated 2023-07-12Non-Small Cell Lung Cancer, Solid Tumor

38. Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

    Active, not recruiting Phase 1 ArriVent BioPharma Started 2022Primary completion 2025-06 NCT05364073

    furmonertinib

    …ge 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Exon 20 Insertion Mutations Inclusion Criteria

    Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations

39. A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer

    Active, not recruiting Phase 1 Nalo Therapeutics Started 2022Primary completion 2025-06 NCT05514496

    NX-019

    Patients with NSCLC with EGFR ex20ins mutations, who are not suitable for, or are unwilling to receive available ex20ins mutati…

    EGFR Mutation-Related Tumors

40. A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Takeda Started 2019Primary completion 2021-11 NCT03807778

    mobocertinib

    A documented EGFR in-frame exon 20 insertion (including A763\_Y764insFQEA, V769\_D770insASV, D770\_N771insNPG, D770\_N771insSVD, H773\…

    Non-Small Cell Lung Cancer

41. A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2019Primary completion 2027-02 NCT04077463

    lazertinibamivantamab FDA EUcarboplatinpemetrexed

    …t must have previously treated, advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation.

    Carcinoma, Non-Small-Cell Lung

42. Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2016Primary completion 2027-06 NCT02496663

    necitumumabosimertinib

    …ting mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q or for EGFR Exon 20 insertion expansion cohort D, NSCLC must harbor an EGFR Exon 20 insertion performed by a Clinical L…

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

43. Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2016Primary completion 2026-12 NCT02609776

    amivantamab FDA EUlazertinibcarboplatinpemetrexed

    …n and L858R (Cohort C, E, and MET-1), as well as marketed TKI-resistant mutations such as Exon 20 insertion (Cohort C, D and MET-1) or activating cMet Exon 14 skipping mutation (Cohort MET-2).

    Non-Small-Cell Lung Cancer

44. Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion

    Recruiting No phase Groupe Francais De Pneumo-Cancerologie Started 2024Primary completion 2026-07 NCT06247826

    Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion

    Non-small Cell Lung Cancer, EGFR Exon 20 Insertion Mutation

45. Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)

    Recruiting No phase Peking Union Medical College Hospital Started 2021Primary completion 2026-12 NCT05559645

    sunvozertinib FDA

    … to standard therapy (except treatment naïve patients in Cohort 4 and Cohort 7: with EGFR Exon20ins

    Non Small Cell Lung Cancer

46. A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2020Primary completion 2024-10 NCT04351555

    osimertinibcisplatincarboplatinpemetrexed

    …del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q).

    Broad match: EGFR exon 20 insertionNon-Small Cell Lung Cancer

47. 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 2026Primary completion 2030-06 NCT07829744

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

    Broad match: EGFR exon 20 insertionLung Cancer (NSCLC)

48. A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer

    Not yet recruiting Phase 1/2 Beijing Pearl Biotechnology Started 2026Primary completion 2029-12 NCT07285148

    PLB1004osimertinib

    …mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples or pleural fluid or blood samples.

    Broad match: EGFR exon 20 insertionNon-Small Cell Lung Cancer, EGFR Mutation, Metastatic Lung Cancer, MET Alteration

49. Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive

    Not yet recruiting Phase 1/2 Avistone Biotechnology Started 2025Primary completion 2028-03 NCT07063329

    PLB1004

    Patients with other EGFR mutations such as EGFR exon 20 insertion: They must have received platinum-based chemotherapy.

    Broad match: EGFR exon 20 insertionNSCLC (Non-small Cell Lung Cancer)

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

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2027-11 NCT06563999

    sunvozertinib FDAcrizotinibpralsetiniblarotrectinibsavolitinibpyrotinibdabrafenibtrametinibglecirasibensartinib

    Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK …

    Broad match: EGFR exon 20 insertionLung Cancer Stage III, Mutation

51. DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)

    Recruiting Phase 2 Dizal Pharmaceuticals Started 2023Primary completion 2025-12 NCT06276283

    sunvozertinib FDAbevacizumab

    …A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.

    Broad match: EGFR exon 20 insertionNon-small Cell Lung Cancer

52. Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2023Primary completion 2027-09 NCT06058988

    trastuzumab deruxtecan

    Her2 mutations must be described to be activating, occur at a known hotspot (e.g. exon 20 insertions, S310, G660, R678, L755, D769, L777), or involve the transmembrane, juxtamembrane or tyr…

    Broad match: EGFR exon 20 insertionBrain Cancer, Glioblastoma, Metastatic Cancer, Leptomeningeal Metastasis

53. Phase I Study of Single-Agent KGX105 in Patients With Advanced or Metastatic Solid Tumors

    Not yet recruiting Phase 1 Kangabio Started 2026Primary completion 2028-09 NCT07702955

    KGX105 injection

    Driver genes primarily include: EGFR exon 19 deletion, L858R mutation, or exon 20 insertion mutation.

    Broad match: EGFR exon 20 insertionAdvanced or Metastatic Solid Tumors

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