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 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 predicted - sensitive Lorlatinib Phase III Actionable In a Phase III trial, patients with previously untreated ALK-positive advanced non-small cell lung cancer treated with Lorbrena (lorlatinib) demonstrated a significantly improved 12-month progression-free survival rate (78% vs 39%; HR=0.28, p<0.001), objective response rate (76%, 113/149 vs 58%, 85/147; OR=2.25), and intracranial response rate (66%, 25/38 vs 20%, 8/40; OR=8.41) compared to patients treated with Xalkori (crizotinib) (PMID: 33207094; NCT03052608). 33207094
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...
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...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 Active, not recruiting USA | CAN 21
NCT02511184 Phase I Crizotinib Pembrolizumab Crizotinib Plus Pembrolizumab In Alk-positive Advanced Non Small Cell Lung Cancer Patients Terminated USA 0
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 USA | CAN 24
NCT04882163 Phase Ib/II Cisplatin + Dexamethasone + Gemcitabine + Iberdomide + Rituximab Lenalidomide + Tafasitamab-cxix Iberdomide + Polatuzumab vedotin-piiq + Rituximab Iberdomide + Tafasitamab-cxix Bendamustine + Polatuzumab vedotin-piiq + Rituximab Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma Withdrawn USA 7
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 3
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 USA 0
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 USA | CAN 22
NCT03052608 Phase III Lorlatinib Crizotinib A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Active, not recruiting USA | CAN 21
NCT03586999 Phase Ib/II Cyclophosphamide + Doxorubicin + Etoposide + Nivolumab + Prednisone + Vincristine Sulfate Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas Active, not recruiting USA 0
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 USA | CAN 18
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 USA | CAN 26
NCT04824092 Phase III Cyclophosphamide + Doxorubicin + Lenalidomide + Prednisone + Rituximab + Tafasitamab-cxix + Vincristine Sulfate Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients (frontMIND) Recruiting USA | CAN 26
NCT02681302 Phase Ib/II Ipilimumab + Nivolumab Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence (CPIT001) Active, not recruiting USA 0
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 USA 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
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 USA 5
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 USA 0
NCT03868423 Phase II Brigatinib Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Recruiting USA 0
NCT02729961 Phase Ib/II Brentuximab vedotin + Ceritinib Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma Withdrawn USA 0
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 USA 0
NCT02343679 Phase II Ceritinib Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies Withdrawn USA 0
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 USA 0
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 USA 0
NCT02463994 Phase I Atezolizumab A Pilot Study of MPDL3280A and HIGRT in Metastatic NSCLC Completed USA 0
NCT01979536 Phase II Crizotinib Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma Active, not recruiting USA 0
NCT01837329 Phase I Tetrathiomolybdate Phase I Study of Tetrathiomolybdate in Combination With Carboplatin/Pemetrexed in Metastatic Non-small Cell Lung Cancer Completed USA 0
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 USA | CAN 19
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 USA | CAN 28
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 USA 0
NCT02232516 Phase II Lenalidomide + Romidepsin Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma Active, not recruiting USA 0
NCT02281409 Phase Ib/II Mogamulizumab Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors Completed USA 0
NCT01947608 Phase I Ceritinib Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC No longer available USA 9
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 USA 0
NCT02094573 Phase II Brigatinib A Phase 2, Multicenter, Randomized Study of AP26113 Completed 0
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 USA 3
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 USA 20
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) Terminated USA 0
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) Active, not recruiting USA 17
NCT03719898 Phase II Brigatinib Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma Withdrawn USA 0
NCT03975114 Phase II Durvalumab + Tremelimumab Durvalumab A Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5) (MILES-5) Recruiting 1
NCT02605746 Phase I Ceritinib Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis Completed USA 0
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 USA 4