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 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...
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
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03838159 Phase II Carboplatin + Nivolumab + Paclitaxel Carboplatin + Paclitaxel NADIM II: Neo-Adjuvant Immunotherapy (NADIMII) Active, not recruiting ESP 0
NCT05221840 Phase III Durvalumab + Oleclumab Durvalumab Durvalumab + Monalizumab A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9) Recruiting USA | ITA | ESP | DEU | CAN 12
NCT04262856 Phase II AB154 + AB928 + Zimberelimab Zimberelimab AB154 + Zimberelimab Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (ARC-7) Recruiting USA | CAN 5
NCT03138889 Phase Ib/II NKTR-214 + Pembrolizumab Carboplatin + Nab-paclitaxel + NKTR-214 + Pembrolizumab Carboplatin + NKTR-214 + Paclitaxel + Pembrolizumab Cisplatin + NKTR-214 + Pembrolizumab Carboplatin + NKTR-214 + Pembrolizumab + Pemetrexed Disodium Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors Active, not recruiting USA | ITA | FRA | ESP | DEU 1
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 USA 1
NCT05211895 Phase III Durvalumab AB154 + Durvalumab A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC Recruiting USA | DEU | BEL 10
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 USA | ITA | FRA | ESP | DEU 1
NCT02289144 Phase II Ceritinib Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer Withdrawn USA 0
NCT02186821 Phase II Ceritinib Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) Terminated USA 0
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 USA 0
NCT04705818 Phase II Durvalumab + Tazemetostat Combining Epigenetic And Immune Therapy to Beat Cancer. (CAIRE) Recruiting FRA 0
NCT04622007 Phase II Pembrolizumab Pembrolizumab + Tomivosertib Tomivosertib With Anti-PD-(L)1 in Subjects With NSCLC. 1st Line Therapy or Progressing on 1st Line Anti-PD-(L)1 Therapy (KICKSTART) Recruiting USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf 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 (TAPUR) Recruiting USA 0
NCT04524689 Phase II Carboplatin + Pembrolizumab + Pemetrexed Disodium + SAR408701 Cisplatin + Pemetrexed Disodium + SAR408701 Carboplatin + Pembrolizumab + SAR408701 Pembrolizumab + SAR408701 Cisplatin + Pembrolizumab + SAR408701 Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC (CARMEN-LC05) Recruiting USA | FRA | ESP 4
NCT03639714 Phase Ib/II GRT-C901 + GRT-R902 + Ipilimumab + Nivolumab A Study of a Personalized Neoantigen Cancer Vaccine Active, not recruiting USA 1
NCT04093167 Phase II Pembrolizumab Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients With NSCLC Active, not recruiting USA | CAN 0
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 USA 0
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 USA | FRA | ESP | CAN 1
NCT04585477 Phase II Durvalumab Adjuvant Durvalumab for Early Stage NSCLC Patients With ctDNA Minimal Residual Disease Recruiting USA 0
NCT05259319 Phase I Atezolizumab + Tiragolumab Study Evaluating the Safety and the Efficacy of Combination of Atezolizumab, Tiragolumab and and Stereotactic Body Radiation Therapy in Patients With Oligometastatic Multiorgan (IMMUNOs-SBRT) (IMMUNOs-SBRT) Not yet recruiting FRA 0
NCT01877083 Phase II Lenvatinib Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung Completed USA 4
NCT04642469 Phase III Durvalumab Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy. (MERMAID-2) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 26
NCT02314364 Phase II A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC Active, not recruiting USA 0
NCT03420508 Phase II Ensartinib Treating Patients With Melanoma and ALK Alterations With Ensartinib Active, not recruiting USA 0
NCT04656652 Phase III Docetaxel Datopotamab Deruxtecan Study of DS-1062A Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 18
NCT02387216 Phase II Seribantumab Pemetrexed Disodium Docetaxel A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC Terminated USA | FRA | ESP | DEU | CAN 1
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 Completed USA 0
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) Completed USA 1
NCT04925986 Phase II Pembrolizumab + Sitravatinib Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC Recruiting USA 0
NCT03696212 Phase Ib/II Grapiprant + Pembrolizumab Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma Terminated USA 0
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 Terminated USA 0
NCT03396497 Phase I LYC-55716 + Pembrolizumab Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer Unknown status USA 0
NCT04116541 Phase II Alectinib Cabozantinib Ribociclib + Siremadlin A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. (MegaMOST) Recruiting FRA 0
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 USA 1
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 Withdrawn 0
NCT03293680 Phase II Pembrolizumab Pembrolizumab in Elderly Patients With Advanced Lung Cancer Recruiting ESP 0
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 USA | ITA | ESP 1
NCT04083976 Phase II Erdafitinib A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 9
NCT00939770 Phase Ib/II Crizotinib Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma Completed USA | CAN 0
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 USA 0
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 USA 0
NCT03175224 Phase Ib/II Bozitinib APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (SPARTA) Recruiting USA | ITA | FRA | ESP | CAN 9
NCT04609566 Phase II Brentuximab vedotin + Pembrolizumab Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors Recruiting USA 0
NCT01752400 Phase II Luminespib AUY922 for Advanced ALK-positive NSCLC Completed USA 0
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 Active, not recruiting USA 0
NCT03475953 Phase Ib/II Avelumab + Regorafenib A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (REGOMUNE) Recruiting FRA 0
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 USA 0
NCT02892123 Phase I Capecitabine + ZW25 ZW25 Paclitaxel + ZW25 Vinorelbine + ZW25 Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers Active, not recruiting USA | CAN 1
NCT04563338 Phase II Atezolizumab Atezolizumab + Bevacizumab An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE) Recruiting CAN 0
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 Active, not recruiting USA | FRA | ESP 3
NCT03906071 Phase III Docetaxel Nivolumab + Sitravatinib Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 5
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 Recruiting CAN 0
NCT01742286 Phase I Ceritinib Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) Completed USA | ITA | FRA | ESP | DEU | CAN 4
NCT04564157 Phase III Carboplatin + Nivolumab + Paclitaxel Carboplatin + Paclitaxel NADIM-ADJUVANT: New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy (NADIM-ADJUVANT) Recruiting ESP 0
NCT01744652 Phase I Crizotinib + Dasatinib Dasatinib and Crizotinib in Advanced Cancer Completed USA 0
NCT04094610 Phase Ib/II Repotrectinib A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations Recruiting USA | CAN 4
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) Recruiting CAN 0