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    BIOMARKER:

    ALK mutation

    i
    Entrez ID:
    238
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Apply
    DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer (KEYNOTE-797) (NCT04042701)
    Phase 1
    Daiichi Sankyo
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    02/10/2020
    Primary completion :
    07/01/2025
    Completion :
    08/01/2025
    EGFR • HER-2 • BRAF • ALK • ROS1
    |
    HER-2 positive • BRAF V600E • EGFR mutation • HR positive • BRAF V600 • HER-2 expression • HER-2 underexpression • ALK mutation • ROS1 fusion
    |
    Keytruda (pembrolizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative (NCT04929041)
    Phase 2/3
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    10/07/2022
    Primary completion :
    12/31/2027
    Completion :
    12/31/2027
    EGFR • PD-L1 • ALK • ROS1
    |
    PD-L1 expression • ALK mutation
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel • albumin-bound paclitaxel • pemetrexed • ABP 206 (nivolumab biosimilar) • Pembroria (pembrolizumab biosimilar) • Pemfexy (pemetrexed)
    Treating Early-stage Non-Small Cell Lung Cancer With Durvalumab and Radiation Therapy (NCT04716946)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    02/13/2025
    Initiation :
    01/27/2021
    Primary completion :
    02/01/2026
    Completion :
    02/01/2026
    EGFR • ALK • CTLA4
    |
    EGFR mutation • ALK mutation
    |
    Imfinzi (durvalumab)
    A Study of ASP1570 Alone or in Combination With Pembrolizumab or Standard Therapies in Adults With Solid Tumors (KEYNOTE-E59) (NCT05083481)
    Phase 1/2
    Astellas Pharma Global Development, Inc.
    Recruiting
    Last update posted :
    02/12/2025
    Initiation :
    10/19/2021
    Primary completion :
    05/31/2028
    Completion :
    05/31/2028
    EGFR • NTRK
    |
    PD-L1 expression • EGFR mutation • ALK positive • ALK mutation • NTRK fusion
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • docetaxel • Lonsurf (trifluridine/tipiracil) • ASP1570
    Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors (KEYNOTE B81) (NCT04609566)
    Phase 2
    Seagen Inc.
    Active, not recruiting
    Last update posted :
    02/07/2025
    Initiation :
    01/26/2021
    Primary completion :
    12/31/2025
    Completion :
    09/30/2026
    EGFR • BRAF • ALK • ROS1
    |
    EGFR mutation • BRAF mutation • ALK mutation
    |
    Keytruda (pembrolizumab) • Adcetris (brentuximab vedotin)
    Treating Patients With Melanoma and ALK Alterations With Ensartinib (NCT03420508)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    01/10/2018
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    BRAF • ALK
    |
    BRAF V600 • ALK fusion • ALK mutation
    |
    Ensacove (ensartinib)
    A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies (ARC-27) (NCT06120075)
    Phase 1
    Arcus Biosciences, Inc.
    Recruiting
    Last update posted :
    01/30/2025
    Initiation :
    01/19/2024
    Primary completion :
    11/01/2026
    Completion :
    11/01/2026
    EGFR • PD-L1 • ALK • MET • RET • ROS1 • STK11 • NTRK
    |
    EGFR mutation • STK11 mutation • ALK mutation
    |
    docetaxel • Yutuo (zimberelimab)
    A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Participants With Advanced Solid Tumors (NCT05858164)
    Phase 1
    Bayer
    Recruiting
    Last update posted :
    01/22/2025
    Initiation :
    08/07/2023
    Primary completion :
    03/02/2027
    Completion :
    03/02/2027
    EGFR • ALK
    |
    EGFR mutation • ALK mutation
    |
    BAY 2862789
    Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 (KEYNOTE-E64) (NCT04787042)
    Phase 1/2
    Simcha IL-18, Inc.
    Recruiting
    Last update posted :
    11/15/2024
    Initiation :
    08/06/2021
    Primary completion :
    06/30/2025
    Completion :
    12/31/2025
    ALK • TMB • MSI
    |
    TMB-H • MSI-H/dMMR • ALK positive • ALK mutation
    |
    Keytruda (pembrolizumab) • Gazyva (obinutuzumab) • vevoctadekin (ST-067)
    A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A72) (NCT03260322)
    Phase 1
    Astellas Pharma Global Development, Inc.
    Completed
    Last update posted :
    11/13/2024
    Initiation :
    09/08/2017
    Primary completion :
    05/10/2022
    Completion :
    05/10/2022
    EGFR • ALK
    |
    EGFR mutation • ALK positive • ALK mutation
    |
    Keytruda (pembrolizumab) • ASP8374
    A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors (KEYNOTE-A87) (NCT03565445)
    Phase 1
    Astellas Pharma Global Development, Inc.
    Completed
    Last update posted :
    11/01/2024
    Initiation :
    07/02/2018
    Primary completion :
    03/27/2023
    Completion :
    03/27/2023
    EGFR • PD-L1 • ALK
    |
    PD-L1 expression • EGFR mutation • PD-L1 overexpression • ALK positive • ALK mutation
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • ASP1948
    Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping (NCT04318938)
    Phase 2
    Institut für Klinische Krebsforschung IKF GmbH ...
    Active, not recruiting
    Last update posted :
    10/14/2024
    Initiation :
    03/30/2020
    Primary completion :
    01/16/2026
    Completion :
    01/16/2026
    ALK • TP53
    |
    TP53 mutation • ALK positive • ALK rearrangement • ALK fusion • ALK mutation
    |
    Alunbrig (brigatinib)
    A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors (NCI-2015-01097) (NCT02498613)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    09/26/2024
    Initiation :
    08/31/2016
    Primary completion :
    06/22/2022
    Completion :
    04/10/2025
    EGFR • HER-2 • ER • PGR
    |
    HER-2 expression • ALK mutation
    |
    Lynparza (olaparib) • Recentin (cediranib)
    Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017 (NCT03003468)
    Phase 1/2
    Lawrence Feldman, MD
    Completed
    Last update posted :
    08/13/2024
    Initiation :
    07/11/2017
    Primary completion :
    11/22/2021
    Completion :
    11/28/2022
    ALK
    |
    EGFR mutation • ALK mutation
    |
    Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
    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 (NCT02091141)
    Phase 2
    Genentech, Inc.
    Completed
    Last update posted :
    07/23/2024
    Initiation :
    04/14/2014
    Primary completion :
    05/24/2023
    Completion :
    05/24/2023
    EGFR • HER-2 • BRAF • ALK • TMB • PTCH1 • SMO
    |
    EGFR mutation • HER-2 overexpression • BRAF mutation • HER-2 amplification • BRAF V600 • ALK rearrangement • ALK mutation • SMO mutation
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • erlotinib • Zelboraf (vemurafenib) • Alecensa (alectinib) • Perjeta (pertuzumab) • Cotellic (cobimetinib) • Erivedge (vismodegib)
    ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (NCT05650879)
    Phase 1
    Enliven Therapeutics
    Recruiting
    Last update posted :
    06/07/2024
    Initiation :
    03/20/2023
    Primary completion :
    07/01/2026
    Completion :
    07/01/2026
    BRAF • ALK • ROS1
    |
    HER-2 positive • BRAF V600E • HER-2 amplification • BRAF V600 • ALK mutation
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ELVN-002
    Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation (PIKACHU) (NCT04322890)
    Phase 2
    Hunan Province Tumor Hospital
    Recruiting
    Last update posted :
    06/04/2024
    Initiation :
    04/16/2020
    Primary completion :
    12/24/2026
    Completion :
    12/24/2027
    EGFR • BRAF • ALK • ROS1
    |
    EGFR mutation • ALK positive • ALK mutation • ROS1 positive • ROS1 mutation
    |
    cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • erlotinib • gefitinib • Rozlytrek (entrectinib) • Alecensa (alectinib) • Lorbrena (lorlatinib) • Zykadia (ceritinib) • pemetrexed • Alunbrig (brigatinib) • Gavreto (pralsetinib) • Ameile (aumolertinib) • Orpathys (savolitinib) • Ivesa (firmonertinib)
    Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy (NCT05584267)
    Phase 2
    Hunan Province Tumor Hospital
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    12/25/2022
    Primary completion :
    11/01/2025
    Completion :
    12/31/2026
    EGFR • ALK • ROS1
    |
    EGFR mutation • ALK mutation
    The Efficacy and Safety of IBI363 in Solid Tumors (Promise) (NCT06081907)
    Phase 1/2
    Hunan Province Tumor Hospital
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    12/25/2023
    Primary completion :
    12/01/2026
    Completion :
    09/01/2028
    EGFR • HER-2 • PD-L1 • BRAF • ALK • RET • CD73 • NTRK
    |
    BRAF V600E • EGFR mutation • BRAF V600 • RET fusion • ALK fusion • ALK mutation
    |
    erlotinib • Lenvima (lenvatinib)
    Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (NCT04837196)
    Phase 1/2
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    05/23/2024
    Initiation :
    12/06/2021
    Primary completion :
    06/30/2024
    Completion :
    06/30/2024
    EGFR • BRAF • ALK • WT1
    |
    EGFR mutation • ALK positive • ALK mutation
    |
    Keytruda (pembrolizumab) • ASP7517
    The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer (NCT05798845)
    Phase 2
    Shanghai Chest Hospital
    Recruiting
    Last update posted :
    05/17/2024
    Initiation :
    02/20/2023
    Primary completion :
    12/01/2024
    Completion :
    12/01/2025
    EGFR • ALK • ROS1
    |
    PD-L1 expression • EGFR mutation • ALK mutation
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi)
    Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy (NCI-2019-03212) (NCT03965689)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    04/16/2020
    Primary completion :
    09/07/2022
    Completion :
    03/20/2025
    BRAF • ALK • ROS1 • B2M • RAD51 • CD4 • NQO1 • NTRK • SLC7A11 • UBE2M • ATF3 • NAE1
    |
    BRAF V600E • EGFR mutation • BRAF V600 • ALK mutation • ROS1 positive • SLC7A11 expression
    |
    carboplatin • paclitaxel • pevonedistat (MLN4924)
    A Study of Combining Cabozantinib and Atezolizumab for Advanced/Metastatic NSCLC (Cabatezo-1) (NCT05859217)
    Phase 2
    Jun Zhang, MD, PhD
    Not yet recruiting
    Last update posted :
    05/08/2024
    Initiation :
    12/01/2024
    Primary completion :
    06/01/2026
    Completion :
    06/01/2028
    EGFR • PD-L1 • BRAF • ALK • CD4
    |
    EGFR mutation • BRAF mutation • ALK mutation
    |
    Tecentriq (atezolizumab) • Cabometyx (cabozantinib tablet)
    A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors (NCT03595059)
    Phase 1
    AbbVie
    Active, not recruiting
    Last update posted :
    05/03/2024
    Initiation :
    07/13/2018
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    EGFR • HER-2 • BRAF • ALK • ROS1
    |
    PD-L1 expression • HER-2 positive • EGFR mutation • HR positive • BRAF mutation • HER-2 negative • ALK mutation • ROS1 positive • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    paclitaxel • docetaxel • mirzotamab clezutoclax (ABBV-155)
    Ramucirumab and Atezolizumab After Progression on Any Immune Checkpoint Blocker in NSCLC (RamAtezo-1) (NCT03689855)
    Phase 2
    Washington University School of Medicine
    Completed
    Last update posted :
    05/02/2024
    Initiation :
    06/05/2019
    Primary completion :
    07/16/2021
    Completion :
    04/22/2024
    EGFR • PD-L1 • ALK
    |
    EGFR mutation • ALK mutation
    |
    Tecentriq (atezolizumab) • Cyramza (ramucirumab)
    Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation (EAGLE) (NCT05491811)
    Phase 2
    Sun Yat-sen University
    Recruiting
    Last update posted :
    05/02/2024
    Initiation :
    08/01/2022
    Primary completion :
    06/30/2024
    Completion :
    12/01/2026
    ALK • TP53
    |
    TP53 mutation • ALK positive • ALK mutation
    |
    Avastin (bevacizumab) • Ensacove (ensartinib)
    Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (STAR-121) (NCT05502237)
    Phase 3
    Gilead Sciences
    Recruiting
    Last update posted :
    05/01/2024
    Initiation :
    10/12/2022
    Primary completion :
    09/01/2027
    Completion :
    09/01/2027
    EGFR • BRAF • ALK • RET • NTRK
    |
    BRAF mutation • ALK mutation • RET mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    Immune and Genomic Markers in ALK+ NSCLC (ENIGMA+) (NCT04881916)
    Phase N/A
    Massachusetts General Hospital
    Recruiting
    Last update posted :
    03/18/2024
    Initiation :
    12/01/2021
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    ALK
    |
    PD-L1 expression • ALK rearrangement • ALK mutation
    Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (VIGOR) (NCT05583188)
    Phase 4
    Galvanize Therapeutics, Inc.
    Active, not recruiting
    Last update posted :
    03/13/2024
    Initiation :
    02/01/2023
    Primary completion :
    06/30/2024
    Completion :
    06/30/2024
    EGFR • ALK
    |
    EGFR mutation • ALK mutation
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • pemetrexed • vinorelbine tartrate
    AB-16B5 Combined With Docetaxel in Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002) (NCT04364620)
    Phase 2
    Alethia Biotherapeutics
    Completed
    Last update posted :
    03/06/2024
    Initiation :
    02/23/2021
    Primary completion :
    12/31/2023
    Completion :
    12/31/2023
    EGFR • PD-L1 • ALK
    |
    EGFR mutation • ALK mutation
    |
    docetaxel • sotevtamab (AB-16B5)
    Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients (NCT02473497)
    Phase N/A
    Pfizer
    No Longer Available
    Last update posted :
    03/04/2024
    ALK • MET • ROS1 • NTRK3 • ETV6
    |
    NTRK3 fusion • ALK mutation • ETV6-NTRK3 fusion • ALK translocation
    |
    Xalkori (crizotinib)
    Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer Patients (NCT03190239)
    Phase 2
    Xinqiao Hospital of Chongqing
    Withdrawn
    Last update posted :
    02/28/2024
    Initiation :
    07/15/2017
    Primary completion :
    07/30/2020
    Completion :
    07/30/2020
    EGFR • ALK
    |
    EGFR mutation • ALK positive • ALK fusion • ALK mutation
    |
    AiTan (rivoceranib) • pemetrexed
    Pemetrexed Plus Apatinib Maintenance Treatment in Patients With Non-squamous Non-small Cell Lung Cancer Patients Who Have Not Progressed After 4 Cycles of Induction Chemotherapy of Pemetrexed in Combination With Platinum-based Regimen (NCT03792503)
    Phase 4
    Xinqiao Hospital of Chongqing
    Withdrawn
    Last update posted :
    02/28/2024
    Initiation :
    02/01/2019
    Primary completion :
    02/01/2020
    Completion :
    02/01/2022
    EGFR • ALK
    |
    EGFR mutation • ALK positive • ALK fusion • ALK mutation
    |
    AiTan (rivoceranib) • pemetrexed
    MG1 Maraba/MAGE-A3, With and Without Adenovirus Vaccine With Transgenic MAGE-A3 Insertion in Incurable MAGE-A3-Expressing Solid Tumours (NCT02285816)
    Phase 1/2
    Canadian Cancer Trials Group
    Active, not recruiting
    Last update posted :
    02/26/2024
    Initiation :
    01/22/2015
    Primary completion :
    09/19/2019
    Completion :
    12/31/2024
    PD-L1 • MAGEA3
    |
    EGFR mutation • ALK mutation
    |
    Marabex (MAGE-A3 vaccine)
    Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors (NCT05757492)
    Phase 1/2
    Coherus Biosciences, Inc.
    Active, not recruiting
    Last update posted :
    02/20/2024
    Initiation :
    04/26/2023
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    EGFR • PD-L1 • ALK • MET • ROS1
    |
    EGFR mutation • ALK mutation • MET mutation • ROS1 mutation
    |
    Loqtorzi (toripalimab-tpzi) • JS006
    PBF-1129 in Patients With NSCLC (NCT03274479)
    Phase 1
    Palobiofarma SL
    Active, not recruiting
    Last update posted :
    02/09/2024
    Initiation :
    10/01/2018
    Primary completion :
    05/01/2024
    Completion :
    08/01/2024
    EGFR • ALK • ROS1
    |
    ALK mutation • ROS1 mutation
    |
    PBF-1129
    Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (PERLA) (NCT04581824)
    Phase 2
    GlaxoSmithKline
    Active, not recruiting
    Last update posted :
    02/07/2024
    Initiation :
    11/19/2020
    Primary completion :
    08/04/2022
    Completion :
    10/20/2025
    EGFR • PD-L1 • BRAF • ALK • ROS1
    |
    BRAF V600E • BRAF V600 • ALK mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • Jemperli (dostarlimab-gxly)
    Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer (NRG-LU008) (NCT05624996)
    Phase 3
    NRG Oncology
    Recruiting
    Last update posted :
    02/07/2024
    Initiation :
    05/10/2023
    Primary completion :
    10/15/2031
    Completion :
    10/15/2036
    EGFR • PD-L1 • ALK
    |
    EGFR mutation • ALK mutation
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • etoposide IV • Pemfexy (pemetrexed)
    Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance (SPACEWALK) (NCT03833934)
    Phase N/A
    Addario Lung Cancer Medical Institute
    Active, not recruiting
    Last update posted :
    02/02/2024
    Initiation :
    01/23/2019
    Primary completion :
    01/01/2024
    Completion :
    06/30/2024
    ALK
    |
    ALK positive • ALK mutation