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OncoMatch/Lung Cancer — Non-Small Cell (NSCLC)/ALK

Lung Cancer — Non-Small Cell (NSCLC)ALK Clinical Trials

68 recruiting trials·Updated daily from ClinicalTrials.gov

ALK gene fusions — most commonly EML4-ALK — occur in 3–5% of NSCLC and are more prevalent in younger, never-smoking patients. Alectinib and lorlatinib are current first-line standards; sequential ALK inhibitors are used upon acquired resistance. Active trials explore next-generation inhibitors and combinations for lorlatinib-resistant disease.

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Additional trials

More ALK Lung Cancer — Non-Small Cell (NSCLC) trials

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Phase 2
NCT06031688Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)Phase 2267 US sitesNCT04302025A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)Phase 238 US sitesNCT05267626Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic CancerPhase 1/Phase 211 US sitesNCT06275360Repositioning Immunotherapy in VetArans With Lung CancerPhase 27 US sitesNCT06007937A Study of Lorlatinib in Combination With Ramucirumab in People With Lung CancerPhase 1/Phase 26 US sitesNCT05456256A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung AdenocarcinomaPhase 26 US sitesNCT07098338A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)Phase 26 US sitesNCT06731907A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)Phase 25 US sitesNCT05987644Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangementsPhase 1/Phase 23 US sitesNCT05715229Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With ImmunotherapyPhase 23 US sitesNCT05877430Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic CancerPhase 1/Phase 22 US sitesNCT07250477Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung CancerPhase 21 US siteNCT07111520A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)Phase 1/Phase 21 US siteNCT05950139Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLCPhase 1/Phase 21 US siteNCT05501665Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung CancerPhase 1/Phase 21 US siteNCT05589818Pembrolizumab for Advanced NSCLC and PS 2-3Phase 21 US siteNCT06364917DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLCPhase 21 US site
7 international trials (no US sites)
NCT06031558Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLCPhase 3NCT07362459A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.Phase 3NCT07016126D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLCPhase 3NCT06793813Cadonilimab in Patients (Pts) with Advanced Non-small Cell Lung Cancer (NSCLC)Phase 2NCT05758116Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC PatientsPhase 2NCT05284539Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung CancerPhase 2NCT05277844Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLCPhase 2
Related therapies

FDA-approved therapies for ALK Lung Cancer — Non-Small Cell (NSCLC)

Approved agents for this molecular target. Indication labels specify the approved patient population — some approvals apply to specific variants only.

LorlatinibThird-generation ALK inhibitorALK-positive metastatic NSCLC, first-line (not previously treated for metastatic disease)AlectinibSecond-generation ALK inhibitorALK-positive metastatic NSCLC, first-lineALK-positive NSCLC, adjuvant after tumor resection (stage IB–IIIA, FDA Apr 2024)
Other Lung Cancer — Non-Small Cell (NSCLC) biomarkers

Browse other molecular targets with active Lung Cancer — Non-Small Cell (NSCLC) trials.

EGFRROS1PD-L1 (CD274)KRASMETHER2 (ERBB2)BRAFRETNTRK1NTRK2NTRK3