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Profile Name ALK fusion
Gene Variant Detail

ALK fusion (unknown)

Relevant Treatment Approaches ALK Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK fusion anaplastic large cell lymphoma sensitive ALK Inhibitor Crizotinib Phase Ib/II Actionable In a Phase Ib/II trial, treatment with Xalkori (crizotinib) resulted in an objective response rate of 83% (5/6, all complete responses), at the 165 mg dose, and 90% (18/20, with complete response in 80% (16/20), at the recommended phase 2 dose of 280 mg, in patients with anaplastic large cell lymphoma harboring an ALK fusion, with 72% of tested patients harboring NPM1-ALK (PMID: 28787259; NCT00939770). 28787259
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Ceritinib FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, Zykadia (ceritinib) resulted in a blinded independent review committee (BIRC)-assessed objective response rate of 44% (72/163) and a duration of response of 7.1 months in ALK-rearranged non-small cell lung cancer patients (PMID: 25754348; NCT01283516). detail... detail... 25754348
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Lorlatinib FDA approved Actionable In a Phase II trial that supported FDA approval, Lorbrena (lorlatinib) treatment resulted in an objective response (OR) rate of 47% (93/198; 4 CR, 89 PR) and a median time to overall first tumor response of 1.4 months, and an objective intracranial response rate of 63% (51/81) and median time to first intracranial response of 1.4 months in ALK-positive (rearrangement or fusion) non-small cell lung cancer patients who had received at least one prior ALK inhibitor therapy (PMID: 30413378; NCT01970865). detail... 30413378
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Lorlatinib Phase I Actionable In a Phase I trial, Lorlatinib (PF-06463922) demonstrated safety and resulted in a 50% (26/52) overall response rate in patients with ALK-positive or ROS1-positive non-small cell lung cancer, including intracranial responses in patients with CNS metastasis (J Clin Oncol 34, 2016 (suppl; abstr 9009)). detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Brigatinib Phase Ib/II Actionable In a phase I/II clinical trial, Alunbrig (brigatinib) was determined to be safe and efficacious in patients with advanced, ALK-fusion positive NSCLC (PMID: 24091716). 24091716
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Brigatinib FDA approved - Has Companion Diagnostic Actionable In a Phase II trial (ALTA) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in an overall response rate of 45% (51/112) in the 90mg arm and 54% (59/110) in the 180mg arm, and median progression-free survival of 9.2 and 11.0 months respectively, in ALK-rearranged (fusion) non-small cell lung carcinoma patients who progressed on Xalkori (crizotinib) (PMID: 28475456; NCT02094573). 28475456 detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Brigatinib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (ALTA-1L) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in superior progression-free survival (HR=0.49, p=0.0007) compared to Xalkori (crizotinib) in patients with ALK-rearrangement positive metastatic non-small cell lung cancer (Ann Oncol., Apr 2019, 30 (Suppl 2):ii48; NCT02737501). detail... detail... detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Ensartinib Phase II Actionable In a Phase II trial, Ensartinib (X-396) treatment resulted in an objective response in 57% (43/75; all partial responses), and stable disease (SD) in 33% (25/75) of patients with crizotinib-refractory non-small cell lung cancer harboring an ALK fusion, with a response rate of 59% and SD rate of 31% in the 70 patients with EML4-ALK, and a response rate of 40% and SD rate of 60% in the 5 patients with non-EML4 ALK fusions (PMID: 31628085; NCT03215693). 31628085
ALK fusion Advanced Solid Tumor predicted - sensitive ALK Inhibitor Repotrectinib Phase I Actionable In a Phase I (TRIDENT-1) trial, Repotrectinib (TPX-0005) treatment resulted in stable disease in 25% (4/16) of patient with advanced solid tumor harboring ALK fusions who completed 2 cycles of treatment (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Alectinib Phase II Actionable In a Phase II trial, treatment with Alecensa (alectinib) resulted in a 49% (60/122) overall response rate in non-small cell lung cancer patients positive for an ALK fusion who had previously progressed on Xalkori (crizotinib) therapy (J Clin Oncol 33, 2015 (suppl; abstr 8008)) detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Alectinib Phase III Actionable In a Phase III trial, treatment with Alecensa (alectinib) resulted in improved progression-free survival compared to treatment with Xalkori (crizotinib) (HR=0.34) in ALK-positive non-small cell lung cancer patients (J Clin Oncol 34, 2016 (suppl; abstr 9008)). detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Alectinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial supporting FDA approval (ALEX), Alecensa (alectinib) treatment resulted in improved rate of progression-free survival compared to Xalkori (crizotinib) (68.4% vs 48.7%, HR=0.47), and median progression-free survival (25.7 vs 10.4 months) in non-small cell lung cancer patients harboring ALK rearrangements (PMID: 28586279; NCT02075840). detail... 28586279 detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK fusion (PMID: 30715168, PMID: 30285222; ESMO.org). 30285222 30715168 detail...
ALK fusion lung non-small cell carcinoma sensitive ALK Inhibitor Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROFILE 1014) that supported FDA approval, Xalkori (crizotinib) treatment resulted in improved progression-free survival (10.9 vs 7.0 months, HR=0.45, p<0.001) and objective response rate (74% vs 45%) relative to chemotherapy in NSCLC patients with ALK rearrangements (PMID: 25470694; NCT01154140). 25470694 detail... detail...
ALK fusion inflammatory myofibroblastic tumor sensitive ALK Inhibitor Crizotinib Phase Ib/II Actionable In a Phase Ib/II trial, treatment with Xalkori (crizotinib) resulted in an objective response rate of 86% (12/14), with complete response in 36% (5/14), in patients with inflammatory myofibroblastic tumor harboring an ALK fusion (PMID: 28787259; NCT00939770). 28787259
Clinical Trial Phase Therapies Title Recruitment Status
NCT03191786 Phase III Atezolizumab Gemcitabine Vinorelbine A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naive Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy (IPSOS) Active, not recruiting
NCT02134886 Phase I Erlotinib Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is Metastatic or Cannot be Removed by Surgery in Patients With HIV Infection Terminated
NCT04471428 Phase III Docetaxel Atezolizumab + Cabozantinib Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy (CONTACT-01) 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
NCT03775486 Phase II Durvalumab + Olaparib Cisplatin + Durvalumab + Pemetrexed Disodium Durvalumab Carboplatin + Durvalumab + Gemcitabine Carboplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Nab-paclitaxel Cisplatin + Durvalumab + Gemcitabine Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) (ORION) Active, not recruiting
NCT04467801 Phase II Ipatasertib Docetaxel + Ipatasertib Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy Not yet recruiting
NCT03999710 Phase II Durvalumab Determining Whether Durvalumab in Combination With Radiation Therapy Can Prevent the Progression of Non-Small Cell Lung Cancer Recruiting
NCT03164616 Phase III Durvalumab + Tremelimumab Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Cisplatin + Gemcitabine Carboplatin + Gemcitabine Durvalumab Carboplatin + Nab-paclitaxel Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). (POSEIDON) Active, not recruiting
NCT04005144 Phase I Binimetinib + Brigatinib Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged 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
NCT04083976 Phase II Erdafitinib A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations Recruiting
NCT04294810 Phase III Atezolizumab Atezolizumab + MTIG7192A A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer (SKYSCRAPER-01) Recruiting
NCT03915951 Phase II Binimetinib + Encorafenib An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer Recruiting
NCT03993873 Phase I TPX-0022 Phase 1 Study of TPX-0022, a MET/CSF1R/SRC Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in MET Recruiting
NCT02587650 Phase II Ceritinib Capmatinib Regorafenib Entrectinib Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma Terminated
NCT03868423 Phase II Brigatinib Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Recruiting
NCT03107988 Phase I Cyclophosphamide + Lorlatinib + Topotecan Lorlatinib NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) Recruiting
NCT03639714 Phase Ib/II GRT-C901 + GRT-R902 + Ipilimumab + Nivolumab A Study of a Personalized Neoantigen Cancer Vaccine Recruiting
NCT03420508 Phase II Ensartinib Treating Patients With Melanoma and ALK Alterations With Ensartinib Active, not recruiting
NCT03255083 Phase I DS-1205c + Osimertinib DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Active, not recruiting
NCT03755102 Phase I Dacomitinib A Study of Dacomitinib in Patients With Metastatic EGFR Mutant Lung Cancer Previously Treated With Osimertinib Recruiting
NCT03066661 Expanded access Entrectinib Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions No longer available
NCT02154490 Phase II Docetaxel Nivolumab Palbociclib Durvalumab Ipilimumab + Nivolumab AZD4547 Taselisib Durvalumab + Tremelimumab Erlotinib + Rilotumumab Talazoparib Erlotinib Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer Active, not recruiting
NCT04094610 Phase Ib/II Repotrectinib A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations Recruiting
NCT04211337 Phase III Vandetanib Cabozantinib Selpercatinib A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) Recruiting
NCT02650401 Phase I Entrectinib Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options (STARTRK-NG) 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
NCT03334617 Phase II AZD9150 + Durvalumab Durvalumab + Olaparib Cediranib + Durvalumab Durvalumab + Vistusertib Durvalumab + Trastuzumab deruxtecan AZD6738 + Durvalumab Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON) Recruiting
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
NCT03563716 Phase II Atezolizumab + MTIG7192A Atezolizumab A Study of MTIG7192A in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Active, not recruiting
NCT00932451 Phase II Crizotinib An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Completed
NCT03037385 Phase Ib/II BLU-667 Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors (ARROW) 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
NCT03057106 Phase II Cisplatin Gemcitabine Carboplatin Durvalumab + Tremelimumab Pemetrexed Disodium Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC Active, not recruiting
NCT00939770 Phase Ib/II Crizotinib Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma Completed
NCT02657434 Phase III Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Atezolizumab + Carboplatin + Pemetrexed Disodium Atezolizumab + Cisplatin + Pemetrexed Disodium A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132) Active, not recruiting
NCT03904108 Phase II Ramucirumab Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy Recruiting
NCT04268550 Phase II Selpercatinib Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial) Recruiting
NCT02949843 Phase II Nivolumab + Pembrolizumab Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations Active, not recruiting
NCT03906071 Phase III Docetaxel MGCD516 + Nivolumab Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous NSCLC Recruiting