crizotinib

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Biomarkers

Sponsors

Industry sponsors leading active biomarker-selected trials of crizotinib.

1. Shenzhen TargetRx 1
2. Pfizer 1
3. Xcovery Holdings 1
4. Guangzhou JOYO Pharma 1
5. Nuvation Bio 1
6. Bristol Myers Squibb 1
7. Roche 1

Trials

17 of 55 trials shown

1. A Phase III Study to Evaluate the Efficacy and Safety of JYP0322 in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

   Not yet recruiting Phase 3 Guangzhou JOYO Pharma Started 2026Primary completion 2028-12 NCT07816380

   JYP0322crizotinib FDA EU

   …dition stage IIIB or IIIC not amenable to multimodality therapy) or metastatic (stage IV) ROS1-positive non-small cell lung cancer (NSCLC).

   ROS1 fusionNSCLC (Advanced Non-small Cell Lung Cancer)

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

   Not yet recruiting Phase 3 Shouyao Holdings Started 2024Primary completion 2026-05 NCT06254599

   SY-3505 Capsulescrizotinib FDA EU

   …s much as possible after signing the ICF and before the first dose for central laboratory ALK fusion positive reconfirmation based on study progression needs). b.

   ALK fusionStatus may be outdated, last updated 2024-02-12Non-small Cell Lung Cancer

3. A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

   Recruiting Phase 3 Nuvation Bio Started 2024Primary completion 2029-01 NCT06564324

   taletrectinib FDAcrizotinib FDA EU

   Have documentation of ROS1 rearrangement by a positive result

   ROS1 fusionNon Small Cell Lung Cancer

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

   Active, not recruiting Phase 3 Shenzhen TargetRx Started 2023Primary completion 2026-04 NCT06082635

   deulorlatinibcrizotinib FDA EU

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

   ALK fusionNon Small Cell Lung Cancer

5. A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

   Active, not recruiting Phase 3 Bristol Myers Squibb Started 2023Primary completion 2027-02 NCT06140836

   repotrectinib FDA EUcrizotinib FDA EU

   Participant has a ROS1 gene rearrangement/fusion as detected by a local test.

   ROS1 fusionCarcinoma, Non-Small-Cell Lung

6. A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases

   Active, not recruiting Phase 3 Roche Started 2021Primary completion 2026-09 NCT04603807

   entrectinib FDA EUcrizotinib FDA EU

   … amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement.

   ROS1 fusionCarcinoma, Non-Small-Cell Lung

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

   Active, not recruiting Phase 3 Pfizer Started 2017Primary completion 2020-03 NCT03052608

   lorlatinib FDA EUcrizotinib FDA EU

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

   ALK fusionCarcinoma, Non-Small-Cell Lung

8. 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 2016Primary completion 2025-12 NCT02767804

   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.

   ALK fusionNon-small Cell Lung Cancer

9. 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 2015Primary completion 2036-05 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 fusionALK Gene Rearrangement, ALK Gene Translocation, ALK Positive, Stage IB Non-Small Cell Lung Carcinoma AJCC v7

10. 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 …

    EGFR exon 20 insertionKRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionLung Cancer Stage III, Mutation

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

    Recruiting Phase 2 Hunan Province Tumor Hospital Started 2021Primary completion 2026-06 NCT05014464

    crizotinib FDA EUalectinib FDA EUbrigatinib FDA EUlorlatinib FDA EUpemetrexedcarboplatinpaclitaxel

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

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

12. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

    aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

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

    EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor

13. Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2016Primary completion 2022-11 NCT06360575

    crizotinib

    Patient must have MET exon 14 skipping as defined via the MATCH Master Protocol and described or other mutations that d…

    MET exon 14 skippingAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm

14. 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 2015Primary completion 2020-03 NCT04439266

    crizotinib FDA EU

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

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

15. Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015Primary completion 2020-03 NCT04439253

    crizotinib FDA EU

    Patients must be positive for translocation or inversion events involving the ROS1 gene via the MATCH Master Protocol

    ROS1 fusionAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma

16. Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015Primary completion 2027-12 NCT02465060

    adavosertibafatinibbinimetinibcapivasertibcopanlisibcrizotinibdabrafenibDasatinibdefactiniberdafitinibfexagratinibipatasertib

    …candidate for Z1M based on local Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (MSI) status by polyme…

    MSI-H / dMMRAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma

17. 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 2014Primary completion 2025-12 NCT02194738

    carboplatincisplatincrizotinib FDA EUerlotinibgemcitabinenivolumabpaclitaxelpembrolizumabpemetrexed

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

    ALK fusionStage 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

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