Molecular Profile Detail

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Profile Name ALK mutant
Gene Variant Detail

ALK mutant (unknown)

Relevant Treatment Approaches

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK mutant lung non-small cell carcinoma no benefit Belizatinib Phase I Actionable In a Phase I trial, treatment with Belizatinib (TSR-011) in ALK inhibitor-naive non-small cell lung cancer patients (n=14) harboring either an ALK mutation, ALK amplification, or an ALK rearrangement resulted in a partial response in 6 patients and stable disease in 8 patients, however, it was determined that the drug resulted in limited efficacy and development of the drug was discontinued (PMID: 31217479; NCT02048488). 31217479
ALK mutant lung non-small cell carcinoma no benefit Crizotinib + Onalespib Phase II Actionable In a Phase II trial, Onalespib (AT13387) and Xalkori (crizotinib) combination treatment did not significantly improve median progression free survival (269 vs 266 days) or objective response rate (55.4%, 38/68 vs 45.3%, 31/68) compared to Xalkori (crizotinib) single treatment in patients with non-small cell lung carcinoma harboring either an ALK mutation or ALK rearrangement (J Clin Oncol 34, 2016 (suppl; abstr 9059); NCT01712217). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT04083976 Phase II Erdafitinib A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations Recruiting
NCT01744652 Phase I Crizotinib + Dasatinib Dasatinib and Crizotinib in Advanced Cancer Completed
NCT03580694 Phase I Cemiplimab + REGN4659 Cemiplimab Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Terminated
NCT02546986 Phase II Azacitidine Pembrolizumab Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer Active, not recruiting
NCT01998126 Phase I Erlotinib + Ipilimumab Crizotinib + Ipilimumab Ipilimumab Plus Targeted Inhibitor (Erlotinib or Crizotinib) for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer: Phase Ib With Expansion Cohorts Completed
NCT04094610 Phase Ib/II Repotrectinib A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations Recruiting
NCT03138889 Phase I NKTR-214 + Pembrolizumab A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 (Pembrolizumab) in Patients With Select Advanced or Metastatic Solid Tumors (PROPEL) Recruiting
NCT02097810 Phase I Entrectinib Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. (STARTRK-1) Active, not recruiting
NCT02314364 Phase II A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC Recruiting
NCT04260802 Phase Ib/II OC-001 + unspecified PD-L1 antibody OC-001 + unspecified PD-1 antibody OC-001 A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers Not yet recruiting
NCT02387216 Phase II Seribantumab Pemetrexed Disodium Docetaxel A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC Completed
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer Recruiting
NCT04267237 Phase II Atezolizumab + RO7198457 Atezolizumab A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer Recruiting
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting
NCT03420508 Phase II Ensartinib Treating Patients With Melanoma and ALK Alterations With Ensartinib Active, not recruiting
NCT03166631 Phase I BI 754091 + BI 891065 BI 891065 A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Recruiting
NCT03213652 Phase II Ensartinib 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) Recruiting
NCT02019979 Phase II Metformin Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (METRO) Terminated
NCT01712217 Phase Ib/II Crizotinib Onalespib A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib Completed
NCT04093167 Phase II Pembrolizumab Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients With NSCLC Recruiting
NCT00939770 Phase Ib/II Crizotinib Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma Completed
NCT03708328 Phase I RO7121661 A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors Recruiting
NCT04266730 Phase I PANDA-VAC + Pembrolizumab + Poly ICLC Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab (PANDA-VAC) Not yet recruiting
NCT02422589 Phase I Warfarin Midazolam Ceritinib A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors Completed
NCT03003468 Phase Ib/II Pembrolizumab + PGG beta-glucan Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017 Recruiting
NCT04262856 Phase II AB154 + AB928 + GLS-010 GLS-010 AB154 + GLS-010 Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (ARC-7) Recruiting
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting
NCT01877083 Phase II Lenvatinib Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung Completed
NCT02091141 Phase II Erlotinib Alectinib Cobimetinib + Vemurafenib Pertuzumab + Trastuzumab Vismodegib Atezolizumab My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Active, not recruiting
NCT03396497 Phase I LYC-55716 + Pembrolizumab Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer Active, not recruiting
NCT02289144 Phase II Ceritinib Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer Withdrawn
NCT01625234 Phase Ib/II Ensartinib Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer Active, not recruiting
NCT03696212 Phase Ib/II Grapiprant + Pembrolizumab Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma Recruiting
NCT03906071 Phase III Docetaxel MGCD516 + Nivolumab Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous NSCLC Recruiting
NCT01752400 Phase II Luminespib AUY922 for Advanced ALK-positive NSCLC Completed
NCT03639714 Phase Ib/II GRT-C901 + GRT-R902 + Ipilimumab + Nivolumab A Study of a Personalized Neoantigen Cancer Vaccine Recruiting
NCT02186821 Phase II Ceritinib Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) Completed
NCT01742286 Phase I Ceritinib Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) Completed