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 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 Advanced Solid Tumor predicted - sensitive Ceritinib Phase I Actionable In a Phase I trial, Zykadia (ceritinib) treatment was well tolerated and resulted in an overall response rate of 14% (1/7), a disease control rate of 43% (3/7), and a progression-free survival of 1.9 months in pediatric patients with ALK-positive advanced solid tumors other than neuroblastoma, anaplastic large cell lymphoma, or inflammatory myofibroblastic tumor (PMID: 34780709; NCT01742286). 34780709
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 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 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 predicted - sensitive Ceritinib Phase I Actionable In a Phase I trial, Zykadia (ceritinib) treatment was well tolerated and resulted in an overall response rate of 20% (6/30; 6 partial response), a disease control rate of 53% (16/30), and a median progression-free survival of 2.4 months in pediatric patients with ALK-positive neuroblastoma (PMID: 34780709; NCT01742286). 34780709
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04334174 Phase II Brentuximab vedotin Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas (BRENTICON-T) Recruiting USA 0
NCT02511184 Phase I Crizotinib Pembrolizumab Crizotinib Plus Pembrolizumab In Alk-positive Advanced Non Small Cell Lung Cancer Patients Terminated 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 | ITA | ESP | DEU | CAN | BEL | AUT 17
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
NCT03719898 Phase II Brigatinib Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma Withdrawn USA 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) Completed USA 3
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
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
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
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
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 | FRA | ESP | BEL | AUT 3
NCT02463994 Phase I Atezolizumab A Pilot Study of MPDL3280A and HIGRT in Metastatic NSCLC Completed USA 0
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
NCT01837329 Phase I Tetrathiomolybdate Phase I Study of Tetrathiomolybdate in Combination With Carboplatin/Pemetrexed in Metastatic Non-small Cell Lung Cancer Completed 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
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
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 | ESP 3
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
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 | ITA | FRA | ESP | DEU | CAN | BEL 14
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
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
NCT02605746 Phase I Ceritinib Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis Completed USA 0
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 | ITA | FRA | ESP | DEU | BEL 15
NCT03975114 Phase II Durvalumab + Tremelimumab Durvalumab A Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5) Recruiting ITA 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
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 | ITA | FRA | ESP 2
NCT01947608 Phase I Ceritinib Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC No longer available USA 9
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) Completed USA | ITA | FRA | ESP | DEU | CAN | BEL 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 | ITA | FRA | ESP | DEU | CAN 24
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
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 | ITA | FRA | ESP | DEU | CAN | BEL 13
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 | ITA | FRA | ESP | DEU | BEL | AUT 11
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 | ITA | FRA | ESP | DEU | CAN | BEL 21
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
NCT02094573 Phase II Brigatinib A Phase 2, Multicenter, Randomized Study of AP26113 Completed 0
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 | ITA | FRA | ESP | DEU | CAN | BEL 16
NCT02729961 Phase Ib/II Brentuximab vedotin + Ceritinib Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma Withdrawn USA 0
NCT02343679 Phase II Ceritinib Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies Withdrawn USA 0
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 15
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
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 | ITA | FRA | ESP | DEU | CAN | AUT 21
NCT05200481 Phase II Brigatinib + Carboplatin + Pemetrexed Disodium Brigatinib Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK) Active, not recruiting FRA 0
NCT03868423 Phase II Brigatinib Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Withdrawn USA 0