Molecular Profile Detail


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Profile Name ALK positive
Gene Variant Detail

ALK positive (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 positive neuroblastoma sensitive Entrectinib Case Reports/Case Series Actionable In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in partial response in a patient with ALK-positive neuroblastoma (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). detail...
ALK positive lung non-small cell carcinoma sensitive Ensartinib Phase II Actionable In a Phase II trial, Ensartinib (X-396) treatment resulted in an objective response in 52% (76/147; all partial responses), and disease control in 93% (137/147) of patients with crizotinib-refractory ALK-positive non-small cell lung cancer, and a median progression-free survival of 9.6 mo., and of the 97 patients with brain metastases, 41% (40) demonstrated a partial response, and of those, 28 (70%) had an intracranial response and 39 (98%) had intracranial disease control (PMID: 31628085; NCT03215693). 31628085
ALK positive lung non-small cell carcinoma sensitive Entrectinib Case Reports/Case Series Actionable In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in stable disease in a patient with ALK-positive non-small cell lung carcinoma (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT03274492 Phase III Polatuzumab vedotin-piiq Cyclophosphamide + Doxorubicin + Prednisone + Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma Recruiting
NCT01828112 Phase III Docetaxel Pemetrexed Disodium Ceritinib LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib Active, not recruiting
NCT02094573 Phase II Brigatinib A Phase 2, Multicenter, Randomized Study of AP26113 Completed
NCT02729961 Phase Ib/II Brentuximab vedotin + Ceritinib Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma Withdrawn
NCT02299505 Phase I Ceritinib Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC) Completed
NCT02584933 FDA approved Ceritinib Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study Recruiting
NCT02075840 Phase III Alectinib Crizotinib A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX) Active, not recruiting
NCT03570892 Phase III Lenalidomide Ibrutinib Carboplatin + Etoposide + Ifosfamide + Rituximab Carmustine + Cytarabine + Etoposide + Melphalan Cisplatin + Dexamethasone + Gemcitabine + Rituximab Cyclophosphamide + Fludarabine + Tisagenlecleucel Cisplatin + Cytarabine + Dexamethasone + Rituximab Gemcitabine + Oxaliplatin + Rituximab Bendamustine + Fludarabine + Tisagenlecleucel Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma (BELINDA) Recruiting
NCT03178552 Phase II Entrectinib Carboplatin + Cisplatin + Gemcitabine Atezolizumab Carboplatin + Cisplatin + Pemetrexed Disodium Atezolizumab + Cobimetinib + Vemurafenib Alectinib A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST) Recruiting
NCT01837329 Phase I Tetrathiomolybdate Phase I Study of Tetrathiomolybdate in Combination With Carboplatin/Pemetrexed in Metastatic Non-small Cell Lung Cancer Completed
NCT03719898 Phase II Brigatinib Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma Recruiting
NCT04002947 Phase II Acalabrutinib + Cyclophosphamide + Doxorubicin + Etoposide + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Doxorubicin + Etoposide + Prednisone + Rituximab + Vincristine Sulfate Acalabrutinib + Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma Recruiting
NCT04163432 Phase II Carboplatin + Durvalumab + Pemetrexed Disodium Durvalumab + Pemetrexed Disodium Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC (STAGGER) Recruiting
NCT01979536 Phase II Crizotinib Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma Suspended
NCT02681302 Phase Ib/II Ipilimumab + Nivolumab Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence (CPIT001) Recruiting
NCT03052608 Phase III Lorlatinib Crizotinib A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Recruiting
NCT03868423 Phase II Brigatinib Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Recruiting
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
NCT03626545 Phase III Canakinumab + Docetaxel Docetaxel Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy (CANOPY-2) Active, not recruiting
NCT02292550 Phase Ib/II Ceritinib + Ribociclib Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. Completed
NCT02281409 Phase Ib/II Mogamulizumab Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors Completed
NCT02797470 Phase Ib/II Carmustine + CCR5 shRNA/TRIM5a/TAR decoy-transduced CD34+ HPCs + Cytarabine + Etoposide + Melphalan Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant Recruiting
NCT02227940 Phase I Ceritinib + Gemcitabine + Nab-paclitaxel Ceritinib + Cisplatin + Gemcitabine Ceritinib + Gemcitabine Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer Completed
NCT02342782 Phase I Carmustine + Cytarabine + Etoposide + Melphalan + Yttrium Y 90 Basiliximab Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma Active, not recruiting
NCT01947608 Phase I Ceritinib Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC Available
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
NCT02767804 Phase III Crizotinib Ensartinib eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients Active, not recruiting
NCT02343679 Phase II Ceritinib Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies Withdrawn
NCT02572453 Phase II Onalespib Testing AT13387 (Onalespib) in Patients With Relapsed/Refractory ALK+ Anaplastic Large Cell Lymphoma (ALCL), Mantle Cell Lymphoma (MCL), and BCL6+ Diffuse Large B Cell Lymphoma (DLBCL) Active, not recruiting
NCT02134912 Phase II Crizotinib + Pemetrexed Disodium Pemetrexed Disodium S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib Terminated
NCT02463994 Phase I Atezolizumab A Pilot Study of MPDL3280A and HIGRT in Metastatic NSCLC Completed
NCT02605746 Phase I Ceritinib Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis Active, not recruiting
NCT02048488 Phase Ib/II Belizatinib A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas Completed
NCT03696784 Phase I Rimiducid Bendamustine + Fludarabine + iC9-CAR.19-IL15-Transduced CB-NK Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma Recruiting
NCT03586999 Phase Ib/II Cyclophosphamide + Doxorubicin + Etoposide + Nivolumab + Prednisone + Vincristine Sulfate Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas Recruiting
NCT02321501 Phase I Ceritinib + Everolimus Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer Recruiting
NCT02232516 Phase II Lenalidomide + Romidepsin Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma Recruiting
NCT00585195 Phase I Crizotinib + Itraconazole Crizotinib + Rifampin A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer (PROFILE 1001) Active, not recruiting
NCT02511184 Phase I Crizotinib Pembrolizumab Crizotinib Plus Pembrolizumab In Alk-positive Advanced Non Small Cell Lung Cancer Patients Terminated