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OncoMatch/Lung Cancer — Non-Small Cell (NSCLC)/ROS1

Lung Cancer — Non-Small Cell (NSCLC)ROS1 Clinical Trials

47 recruiting trials·Updated daily from ClinicalTrials.gov

ROS1 fusions occur in approximately 1–2% of NSCLC and are actionable targets for ROS1-directed TKIs. FDA-approved options for locally advanced or metastatic ROS1-positive NSCLC include crizotinib, entrectinib, repotrectinib, and taletrectinib. Repotrectinib and taletrectinib are approved for both TKI-naïve and previously ROS1-TKI-treated patients. Active trials investigate later-line strategies, CNS-active agents, combinations, and resistance mechanisms.

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Additional trials

More ROS1 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 sitesNCT06275360Repositioning Immunotherapy in VetArans With Lung CancerPhase 27 US sitesNCT01639508Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL ActivityPhase 27 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 sitesNCT05715229Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With ImmunotherapyPhase 23 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 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
13 international trials (no US sites)
NCT07016126D-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 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 2NCT06563999Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.Phase 2NCT06917573PALACE: Cemiplimab Trial According to ctDNA LevelsPhase 2NCT06849167Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in LA-NSCLCPhase 2NCT06315010REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasisPhase 2NCT04996121A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid TumorsPhase 1/Phase 2NCT07153445Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)Phase 2NCT06929936Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLCPhase 2NCT05765877Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung CancerPhase 2NCT06574347Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.Phase 2
Related therapies

FDA-approved therapies for ROS1 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.

EntrectinibROS1 and TRK inhibitorROS1-positive metastatic NSCLC (FDA Aug 2019)RepotrectinibNext-generation ROS1/TRK inhibitorROS1-positive metastatic NSCLC (FDA Nov 2023)TaletrectinibNext-generation ROS1 inhibitorROS1-positive locally advanced or metastatic NSCLC (FDA Jun 2025)
Other Lung Cancer — Non-Small Cell (NSCLC) biomarkers

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

EGFRALKPD-L1 (CD274)KRASMETHER2 (ERBB2)BRAFRETNTRK1NTRK2NTRK3