Molecular Profile Detail

Profile Name ROS1 rearrange
Gene Variant Detail

ROS1 rearrange (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 rearrange non-small cell lung carcinoma sensitive ROS1 Inhibitor Lorlatinib Phase I Actionable In a Phase I trial, Lorlatinib (PF-06463922) treatment resulted in an objective response in 50% (6/12) of patients with non-small cell lung carcinoma harboring a ROS1 rearrangement (PMID: 29074098; NCT03052608). 29074098
ROS1 rearrange non-small cell lung carcinoma sensitive ROS1 Inhibitor Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as the preferred first-line therapy for ROS1 rearranged non-small cell lung cancer (NCCN.org). detail...
ROS1 rearrange non-small cell lung 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). 25264305
ROS1 rearrange non-small cell lung carcinoma sensitive ROS1 Inhibitor Entrectinib Phase I Actionable In a clinical study analyzing combined results of 2 Phase I trials, Entrectinib (RXDX-101) treatment resulted in complete response in 2 and partial response in 10 patients with ROS-1 rearranged non-small cell lung carcinoma that were treatment-naive (PMID: 28183697). 28183697
ROS1 rearrange non-small cell lung carcinoma no benefit Gefitinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ROS1 rearrange lung adenocarcinoma sensitive ROS1 Inhibitor Crizotinib Phase I Actionable In a retrospective analysis of Phase I clinical data, Xalkori (crizotinib) resulted in an objective response rate of 80% (24/30) and a median PFS of 9.1 months in patients with ROS1 rearranged lung adenocarcinoma (PMID: 25667280). 25667280
ROS1 rearrange non-small cell lung carcinoma sensitive ROS1 Inhibitor Ceritinib Guideline Actionable Zykadia (ceritinib) is included in guidelines as first-line therapy for ROS1 rearranged non-small cell lung cancer, but is not indicated after patients became resistant to Xalkori (crizotinib) (NCCN.org). detail...
ROS1 rearrange non-small cell lung carcinoma sensitive ROS1 Inhibitor Ceritinib Phase II Actionable In a Phase II trial, treatment with Zykadia (ceritinib) resulted in an overall response rate of 62% (20/32, including 1 complete response), a disease control rate of 81% (26/32), and a progression-free survival of 9.3 months in all patients and 19.3 months in Xalkori (crizotinib)-naive patients with non-small cell lung cancer harboring a ROS1 rearrangement (PMID: 28520527; NCT01964157). 28520527
ROS1 rearrange non-small cell lung carcinoma no benefit Alectinib Guideline Actionable Alecensa (alectinib) is not indicated for use in ROS1 rearranged non-small cell lung cancer patients whose disease became resistant to Xalkori (crizotinib) (NCCN.org). detail...
ROS1 rearrange non-small cell lung carcinoma sensitive NPS-1034 Preclinical - Cell culture Actionable In a preclinical study, NPS-1034 inhibited ROS1 activity and proliferation of a non-small cell lung cancer cell line harboring a ROS1 rearrangement in culture (PMID: 24165158). 24165158
ROS1 rearrange non-small cell lung carcinoma no benefit Afatinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ROS1 rearrange non-small cell lung carcinoma no benefit Osimertinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ROS1 rearrange non-small cell lung carcinoma predicted - sensitive ROS1 Inhibitor Cabozantinib Clinical Study Actionable In a clinical case study, a patient with ROS1-rearranged non-small cell lung cancer with acquired resistance to Xalkori (crizotinib) demonstrated partial response to treatment with Cometriq (cabozantinib) prior to progressing after approximately 10 weeks (PMID: 27370605). 27370605
ROS1 rearrange Advanced Solid Tumor sensitive ROS1 Inhibitor Entrectinib Phase I Actionable In a clinical study analyzing combined results of 2 Phase I trials, Entrectinib (RXDX-101) treatment resulted in an objective response rate of 86% (12/14) in patients with ROS-1 rearranged advanced solid tumors that were treatment-naive, but no response (0/6) in patients received prior Xalkori (crizotinib) (PMID: 28183697). 28183697
ROS1 rearrange Advanced Solid Tumor sensitive ROS1 Inhibitor Entrectinib Phase I Actionable In a Phase I trial, Entrectinib (RXDX-101) treatment resulted in complete response in 13% (1/12) and objection response in 75% (6/8) of patients with advanced solid tumors harboring rearrangement in ROS1 gene (AACR Apr 2016, Abstract # CT007). detail...
ROS1 rearrange non-small cell lung carcinoma no benefit Erlotinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT03348904 Phase III Carboplatin + Cisplatin + Gemcitabine + Nivolumab + Paclitaxel + Pemetrexed Carboplatin + Cisplatin + Gemcitabine + Paclitaxel + Pemetrexed Carboplatin + Cisplatin + Epacadostat + Gemzar + Nivolumab + Taxol + Pemetrexed Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer Terminated
NCT03322540 Phase III Pembrolizumab Epacadostat + Pembrolizumab Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer Active, not recruiting
NCT03425006 Phase II Itacitinib + Pembrolizumab Pembrolizumab and Itacitinib (INCB039110) for NSCLC 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
NCT03421353 Phase Ib/II AZD9150 + Cisplatin + Durvalumab + Gemcitabine AZD9150 + Carboplatin + Durvalumab + Gemcitabine AZD9150 + Cisplatin + Durvalumab + Fluorouracil AZD9150 + Durvalumab AZD9150 + Carboplatin + Durvalumab + Nab-paclitaxel AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer Recruiting
NCT03559049 Phase Ib/II Carboplatin + Pembrolizumab + Pemetrexed + Rucaparib Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer Recruiting
NCT03093116 Phase Ib/II Ropotrectinib A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements Recruiting
NCT01970865 Phase Ib/II Lorlatinib Crizotinib A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations Active, not recruiting
NCT03664024 Phase II Pemetrexed + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Cisplatin + Pembrolizumab + Pemetrexed Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782) (KEYNOTE-782) Recruiting
NCT03322566 Phase III Epacadostat + Pembrolizumab Paclitaxel + Carboplatin Cisplatin + Pemetrexed Carboplatin + Pemetrexed Pembrolizumab Plus Epacadostat Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer Active, not recruiting
NCT03087448 Phase Ib/II Ceritinib + Trametinib Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Recruiting
NCT03157128 Phase I LOXO-292 Phase 1 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET-Fusion Lung Cancer and Medullary Thyroid Cancer Recruiting
NCT03468985 Phase II Cabozantinib + Nivolumab Cabozantinib + Ipilimumab + Nivolumab Nivolumab Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung Cancer Suspended
NCT03472560 Phase II Avelumab + Axitinib A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF) Recruiting
NCT03516981 Phase II MK-4280 + Pembrolizumab Lenvatinib + Pembrolizumab A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495) Recruiting
NCT02650401 Phase I Entrectinib Study of RXDX-101 in Children With Recurrent or Refractory Solid Tumors and Primary CNS Tumors Recruiting
NCT03317496 Phase II Avelumab + Cisplatin + Gemcitabine Avelumab + Carboplatin + Pemetrexed Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies Recruiting
NCT03308942 Phase II Niraparib Phase 2, Multi-Arm Study of Niraparib Administered Alone and in Combination With PD-1 Inhibitor in Patients With Non-Small Cell Lung Cancer Recruiting
NCT02568267 Phase II Entrectinib Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (STARTRK-2) Recruiting
NCT02279433 Phase I DS6051b A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b Active, not recruiting
NCT03334617 Phase II AZD9150 + Durvalumab Durvalumab + Olaparib Durvalumab + Vistusertib AZD6738 + MEDI4736 Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy. (HUDSON) Recruiting
NCT02465060 Phase II Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT03417037 Phase III BMS-986205 + Nivolumab An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer Withdrawn
NCT03696212 Phase Ib/II Grapiprant + Pembrolizumab Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma Recruiting
NCT03088930 Phase II Crizotinib Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer Recruiting
NCT02473497 Expanded access Crizotinib Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients Available
NCT03631706 Phase II M7824 Pembrolizumab M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC) Recruiting
NCT02879617 Phase II Durvalumab A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients Recruiting
NCT02927340 Phase II Lorlatinib A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions Recruiting
NCT03064854 Phase I Carboplatin + Paclitaxel + PDR001 Cisplatin + Pemetrexed + PDR001 Cisplatin + Gemcitabine + PDR001 Pemetrexed + PDR001 + Cisplatin + Carboplatin PDR001 in Combination With Platinum-doublet Chemotherapy in PD-L1 Unselected, Metastatic NSCLC Patients (ElevatION:NSCLC-101 Trial) Recruiting