Molecular Profile Detail

Profile Name ROS1 fusion
Gene Variant Detail

ROS1 fusion (unknown)

Relevant Treatment Approaches ROS1 Inhibitor


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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 fusion lung non-small cell carcinoma predicted - sensitive ROS1 Inhibitor DS6051b Phase I Actionable In a Phase I clinical trial, DS-6051b was well-tolerated and demonstrated some preliminary efficacy in patients with advanced solid tumors, including a partial response in a patient with non-small cell lung cancer liver metastases harboring a ROS1 fusion (Cancer Res July 15 2016 (76) (14 Supplement) CT024). detail...
ROS1 fusion Advanced Solid Tumor predicted - sensitive ROS1 Inhibitor Repotrectinib Phase I Actionable In a Phase I (TRIDENT-1) trial, Repotrectinib (TPX-0005) treatment resulted in partial response in 21.6% (8/37) of patients with advanced solid tumors harboring ROS1 or NTRK fusions (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). detail...
ROS1 fusion Advanced Solid Tumor sensitive ROS1 Inhibitor Brigatinib Preclinical - Cell culture Actionable In a preclinical study, Alunbrig (brigatinib) inhibited growth of transformed cells expressing ROS1 fusion proteins in culture (PMID: 27780853). 27780853
ROS1 fusion lung non-small cell carcinoma sensitive ROS1 Inhibitor Lorlatinib Phase I Actionable In a Phase I clinical trial, Lorlatinib (PF-06463922) demonstrated safety and resulted in a 50% (26/52) overall response rate in patients with ALK-positive or ROS1-positive non-small cell lung cancer, including intracranial responses in patients with CNS metastasis (J Clin Oncol 34, 2016 (suppl; abstr 9009)). detail...
ROS1 fusion lung non-small cell carcinoma sensitive ROS1 Inhibitor Crizotinib FDA approved Actionable In a Phase I trial that supported FDA approval, non-small cell lung cancer patients with ROS1 rearrangements treated with Xalkori (crizotinib) demonstrated an objective response rate of 72% (36/50), with 3 complete responses and 33 partial responses, a median duration of response of 17.6 months, and a median progression-free survival of 19.2 months (PMID: 25264305; NCT00585195) and requires FDA-approved test. detail... 25264305
Clinical Trial Phase Therapies Title Recruitment Status
NCT02097810 Phase I Entrectinib Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. (STARTRK-1) Active, not recruiting
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting
NCT02949843 Phase II Nivolumab + Pembrolizumab Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations Active, not recruiting
NCT03409614 Phase III Cemiplimab + Ipilimumab Cemiplimab REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer Recruiting
NCT04005144 Phase I Binimetinib + Brigatinib Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer Not yet recruiting
NCT03260491 Phase I U3-1402 U3-1402 in Metastatic or Unresectable EGFR-mutant Non-Small Cell Lung Cancer Recruiting
NCT01449461 Phase Ib/II Brigatinib A Phase 1/2 Study of the Oral ALK/EGFR Inhibitor AP26113 Active, not recruiting
NCT03868423 Phase II Brigatinib Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Not yet recruiting
NCT03213652 Phase II Ensartinib Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) Recruiting
NCT03066661 Expanded access Entrectinib Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions No longer available
NCT02587650 Phase II Ceritinib Capmatinib Regorafenib Entrectinib Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma Completed
NCT03993873 Phase I TPX-0022 Phase 1 Study of TPX-0022, a MET/CSF1R/SRC Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in MET Not yet recruiting
NCT03639714 Phase Ib/II GRT-C901 + GRT-R902 + Ipilimumab + Nivolumab A Study of a Personalized Neoantigen Cancer Vaccine Recruiting
NCT03430063 Phase II Cemiplimab + Ipilimumab Cemiplimab A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer Active, not recruiting
NCT01639508 Phase II Cabozantinib Cabozantinib 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 Activity Recruiting
NCT02892123 Phase I Capecitabine + ZW25 ZW25 Paclitaxel + ZW25 Vinorelbine + ZW25 Trial of ZW25 in Patients With Advanced HER2-expressing Cancers Recruiting
NCT02314364 Phase II A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC Recruiting
NCT03515629 Phase III Cemiplimab + Ipilimumab Pembrolizumab REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer Active, not recruiting
NCT03037385 Phase I BLU-667 Phase 1 Study of BLU-667 in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Recruiting
NCT03166631 Phase I BI 754091 + BI 891065 BI 891065 A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Recruiting
NCT03255083 Phase I DS-1205c + Osimertinib DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Recruiting
NCT03580694 Phase I Cemiplimab + REGN4659 Cemiplimab Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Recruiting