Molecular Profile Detail

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 lung non-small cell carcinoma sensitive Entrectinib Phase I Actionable In a Phase I trial, Entrectinib (RXDX-101) 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...
ALK positive lung non-small cell carcinoma sensitive Ensartinib Phase Ib/II Actionable In a Phase Ib/II trial, Ensartinib (X-396) treatment resulted in partial response (PR) in 60% (19/30) and stable disease in 7% (2/30) of ALK positive non-small cell lung carcinoma patients, PR was 88% (7/8) in crizotinib-naïve patients and 83% (10/12) in patients with prior crizotinib treatment (J Clin Oncol 34, 2016 (suppl; abstr 9056)). detail...
ALK positive neuroblastoma sensitive Entrectinib Phase I Actionable In a Phase I trial, Entrectinib (RXDX-101) treatment resulted in partial response in a patient with ALK-positive neuroblastoma (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). detail...
ALK positive Advanced Solid Tumor sensitive Belizatinib Phase Ib/II Actionable In a Phase I trial, Belizatinib (TSR-011) treatment resulted in a response in 100% (3/3) of patients with ALK positive advanced solid tumors when administered at higher doses, and stable disease for 7 months or longer in 56% (5/9) of patients at lower dose (J Clin Oncol 33, 2015 (suppl; abstr 8063)). detail...
ALK positive 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 ALK positive non-small cell lung carcinoma patients (J Clin Oncol 34, 2016 (suppl; abstr 9059); NCT01712217). detail...
ALK positive lung non-small cell carcinoma sensitive Belizatinib Phase I Actionable In a Phase I clinical trial, Belizatinib (TSR-011) treatment resulted in a partial response in 60% (3/5) of non-small cell lung cancer patients positive for Alk (J Clin Oncol 32, 2014 (suppl; abstr e19005)). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02681302 Phase Ib/II Ipilimumab + Nivolumab Study of Combined Check Point Inhibition After Autologous Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence (CPIT001) Recruiting
NCT02075840 Phase III Alectinib Crizotinib ALEX Study: A Randomized, Phase III Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Active, not recruiting
NCT02729961 Phase Ib/II Brentuximab vedotin + Ceritinib Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma Recruiting
NCT02321501 Phase I Ceritinib + Everolimus Ceritinib Phase I/Ib Dose Escalation and Biomarker Study of Ceritinib (LDK378) + Everolimus for Locally Advanced or Metastatic Solid Tumors With an Expansion in Non-Small Cell Lung Cancer (NSCLC) Characterized by Abnormalities in Anaplastic Lymphoma Kinase (ALK) Expression 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 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
NCT02511184 Phase I Crizotinib Pembrolizumab Crizotinib Plus Pembrolizumab In Alk-positive Advanced Non Small Cell Lung Cancer Patients Terminated
NCT02094573 Phase II Brigatinib A Phase 2, Multicenter, Randomized Study of AP26113 Active, not recruiting
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
NCT02767804 Phase III Crizotinib Ensartinib eXalt3: Study Comparing X-396 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients Active, not recruiting
NCT03052608 Phase III Lorlatinib Crizotinib A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Recruiting
NCT02232516 Phase II Lenalidomide + Romidepsin Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma Recruiting
NCT02134912 Phase II Crizotinib + Pemetrexed Pemetrexed 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
NCT03274492 Phase III Polatuzumab vedotin-piiq Cyclophosphamide + Doxorubicin + Prednisone + Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine 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
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 Active, not recruiting
NCT03719898 Phase II Brigatinib Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma Recruiting
NCT03868423 Phase II Brigatinib Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Not yet recruiting
NCT03586999 Phase Ib/II Cyclophosphamide + Doxorubicin + Etoposide + Nivolumab + Prednisone + Vincristine Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas 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
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) Recruiting
NCT02605746 Phase I Ceritinib Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis Unknown status
NCT01828112 Phase III Docetaxel Pemetrexed Ceritinib LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib Active, not recruiting
NCT03178552 Phase II Entrectinib Carboplatin + Cisplatin + Gemcitabine Atezolizumab Carboplatin + Cisplatin + Pemetrexed 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
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
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
NCT02281409 Phase Ib/II Mogamulizumab Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors Recruiting
NCT02342782 Phase I 90Y basiliximab + Carmustine + Cytarabine + Etoposide + Melphalan Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma 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 Active, not recruiting
NCT02572453 Phase II Onalespib AT13387 in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Diffuse Large B-cell Lymphoma Recruiting
NCT01947608 Phase I Ceritinib Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC Available
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
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) Active, not recruiting
NCT04002947 Phase II Acalabrutinib + Cyclophosphamide + Doxorubicin + Etoposide + Prednisone + Rituximab + Vincristine Cyclophosphamide + Doxorubicin + Etoposide + Prednisone + Rituximab + Vincristine Acalabrutinib + Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma Not yet recruiting
NCT02343679 Phase II Ceritinib Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies Withdrawn
NCT01837329 Phase I Tetrathiomolybdate Phase I Study of Tetrathiomolybdate in Combination With Carboplatin/Pemetrexed in Metastatic Non-small Cell Lung Cancer Completed
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