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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 lung non-small cell carcinoma sensitive ROS1 Inhibitor Ceritinib Guideline Actionable Zykadia (ceritinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement who have not received prior Xalkori (crizotinib) therapy (PMID: 32169226; ESMO.org). detail... 32169226
ROS1 rearrange lung non-small cell 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 become resistant to Xalkori (crizotinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell 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 lung non-small cell carcinoma sensitive ROS1 Inhibitor Lorlatinib Phase I Actionable In a Phase I trial, Lorbrena (lorlatinib) 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 lung non-small cell carcinoma sensitive ROS1 Inhibitor Lorlatinib Guideline Actionable Lorbrena (lorlatinib) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement, or as a next-line therapy in patients with ROS1-rearranged non-small cell lung cancer who have not received prior ROS1 inhibitor therapy (PMID: 32169226, Version Update 15 Sept 2020; ESMO.org). 32169226 detail...
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Lorlatinib Phase Ib/II Actionable In a Phase I/II trial, Lorbrena (lorlatinib) treatment resulted in an objective response rate of 62% (13/21) in tyrosine kinase inhibitor (TKI)-naive and 35% (14/40) in previous Xalkori (crizotinib)-treated patients with non-small cell lung cancer harboring ROS1 rearrangements, intracranial responses were observed in 64% (7/11) of TKI-naive patients and 50% (12/24) of previous Xalkori (crizotinib)-treated patients (PMID: 31669155; NCT01970865). 31669155
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Lorlatinib Guideline Actionable Lorbrena (lorlatinib) is included in guidelines as subsequent therapy in patients with advanced or metastatic ROS1-rearranged non-small lung cancer (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Repotrectinib Guideline Actionable Repotrectinib (TPX-0005) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement, or as a next-line therapy in patients with ROS1-rearranged non-small cell lung cancer who have not received prior ROS1 inhibitor therapy (PMID: 32169226, Version Update 15 Sept 2020; ESMO.org). detail... 32169226
ROS1 rearrange lung non-small cell 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 lung non-small cell carcinoma sensitive ROS1 Inhibitor Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase I trial (PROFILE 1001) that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate of 72% (38/53), with 6 complete responses and 32 partial responses, a median duration of response of 24.7 months, a median progression-free survival of 19.3 months, and a median overall survival of 51.4 months in patients with non-small cell lung cancer harboring ROS1 rearrangements as detected by an FDA-approved test (PMID: 30980071; NCT00585195). detail... detail... 30980071
ROS1 rearrange lung non-small cell 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 lung non-small cell carcinoma sensitive ROS1 Inhibitor Crizotinib Phase II Actionable In a Phase II clinical trial, patients with non-small cell lung cancer harboring a ROS1 rearrangement demonstrated an objective response rate of 70% (21/30; all partial response), a median progression-free survival (PFS) of 20 months, a duration of response of 19 months, and a survival rate of 83% at 12 months and 63% at 24 months, when treated with Xalkori (crizotinib) (PMID: 30978502; NCT02183870). 30978502
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Crizotinib Phase II Actionable In a Phase II trial (AcSe), treatment with Xalkori (crizotinib) resulted in a an overall response rate after 2 cycles of 47.2% (17/36; all partial responses), and after 4 cycles resulted in a best overall response rate of 69.4% (21/36; 20 partial responses and 1 complete response), and a median progression-free survival of 5.5 months and median overall survival of 17.2 months in patients with ROS1-translocated non-small cell lung cancer (PMID: 31584608; NCT02034981). 31584608
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement, or as a next-line therapy in patients with ROS1-rearranged non-small cell lung cancer who have not received prior Xalkori (crizotinib) therapy (PMID: 32169226; ESMO.org). detail... 32169226
ROS1 rearrange lung non-small cell 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 lung non-small cell carcinoma no benefit ROS1 Inhibitor Brigatinib Guideline Actionable Alunbrig (brigatinib) 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 lung non-small cell carcinoma no benefit ROS1 Inhibitor Brigatinib Case Reports/Case Series Actionable In a retrospective analysis, Alunbrig (brigatinib) treatment resulted in a partial response in a patient with Xalkori (crizotinib)-naive non-small cell lung cancer (NSCLC) harboring ROS1 rearrangement, and resulted in 1 partial response and 1 stable disease in 7 patients with Xalkori (crizotinib)-resistant NSCLC harboring ROS1 rearrangements (PMID: 32462394). 32462394
ROS1 rearrange lung non-small cell 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 Advanced Solid Tumor sensitive ROS1 Inhibitor Entrectinib Phase I Actionable In a clinical study, combined analysis of 2 Phase I trials showed Rozlytrek (entrectinib) treatment to result 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 who received prior Xalkori (crizotinib) (PMID: 28183697). 28183697
ROS1 rearrange Advanced Solid Tumor sensitive ROS1 Inhibitor Entrectinib Phase I Actionable In a Phase I trial, Rozlytrek (entrectinib) 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 Advanced Solid Tumor predicted - sensitive ROS1 Inhibitor TQ-B3101 Case Reports/Case Series Actionable In a Phase I trial, TQ-B3101 treatment was well tolerated and resulted in an objective response rate (ORR) of 62.5% (15/24) in patients with ALK-positive, ROS1-positive, or MET-amplified advanced solid tumors, with an ORR of 62.5% (5/8) in patients with brain metastases (J Clin Oncol 38, 2020 (suppl 15; abstr e21705); NCT03019276). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor WX-0593 Phase I Actionable In a Phase I trial, WX-0593 (iruplinalkib) demonstrated safety and resulted in an objective response rate (ORR) of 56.6% (56/99; all partial responses) and a disease control rate (DCR) of 83.8% (83/99), and median duration of response and median progression-free survival were not reached in non-small cell lung cancer patients with an ALK or ROS1-rearrangement, with an ORR of 44.4% (4/9) and DCR of 66.7% (6/9) in patients with a ROS1 rearrangement (PMID: 35087031). 35087031
ROS1 rearrange lung non-small cell carcinoma predicted - sensitive ROS1 Inhibitor Taletrectinib Phase I Actionable In a Phase I trial, Taletrectinib (DS6051b) demonstrated manageable toxicity, resulted in an objective response rate of 33.3% (2/6) in patients with advanced non-small cell lung cancer harboring ROS1 rearrangements (PMID: 32591465). 32591465
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Entrectinib Phase I Actionable In a clinical study, combined analysis of 2 Phase I trials showed Rozlytrek (entrectinib) treatment to result in complete response in 15% (2/13) and partial response in 77% (10/13) patients with ROS-1 rearranged non-small cell lung carcinoma that were treatment-naive (PMID: 28183697). 28183697
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Entrectinib Guideline Actionable Rozlytrek (entrectinib) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement, or as a next-line therapy in patients with ROS1-rearranged non-small cell lung cancer who have not received prior ROS1 inhibitor therapy (PMID: 32169226, Version Update 15 Sept 2020; ESMO.org). 32169226 detail...
ROS1 rearrange lung non-small cell carcinoma sensitive ROS1 Inhibitor Entrectinib Guideline Actionable Rozlytrek (entrectinib) is included in guidelines as a preferred therapy for patients with advanced or metastatic ROS1 rearrangement-positive non-small cell lung cancer (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 lung non-small cell 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 non-small cell 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 lung non-small cell 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 Covered Countries Other Countries
NCT04265534 Phase II Carboplatin + Dexamethasone + Pembrolizumab + Pemetrexed Disodium + Telaglenastat Carboplatin + Dexamethasone + Pembrolizumab + Pemetrexed Disodium KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC (KEAPSAKE) Terminated USA 0
NCT04621188 Phase II Lorlatinib Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) Recruiting FRA 0
NCT04725188 Phase II Docetaxel Docetaxel + MK-7684A MK-7684A Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002) Active, not recruiting USA | ITA | FRA | ESP | DEU | BEL | AUT 13
NCT04033354 Phase III Carboplatin + Nab-paclitaxel + Serplulimab Carboplatin + Nab-paclitaxel A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC Active, not recruiting USA 6
NCT03322540 Phase II Pembrolizumab Epacadostat + Pembrolizumab Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05) Completed USA | ITA | ESP | CAN 14
NCT03087448 Phase Ib/II Ceritinib + Trametinib Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Terminated USA 0
NCT05241873 Phase Ib/II BLU-451 Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations Recruiting USA 0
NCT04862780 Phase Ib/II BLU-945 Study Targeting EGFR Resistance Mechanisms in NSCLC Recruiting USA | ESP 7
NCT05005273 Phase II Ipilimumab + Nivolumab BMS-986207 + Ipilimumab + Nivolumab A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer Not yet recruiting USA | ITA | FRA | ESP | DEU | BEL 7
NCT05012254 Phase II Ipilimumab + Nivolumab Carboplatin + Ipilimumab + Nivolumab + Paclitaxel Cisplatin + Ipilimumab + Nivolumab + Pemetrexed Disodium Carboplatin + Ipilimumab + Nivolumab + Pemetrexed Disodium Study of Nivolumab and Ipilimumab Plus Chemotherapy as a Treatment for Patients With Stage IV Lung Cancer With Brain Metastases (NIVIPI-Brain) Recruiting ESP 0
NCT03664024 Phase II Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782) (KEYNOTE-782) Completed USA | ESP | CAN 2
NCT04623775 Phase II Cisplatin + Nab-paclitaxel + Nivolumab + Pemetrexed Disodium Cisplatin + Nivolumab + Paclitaxel + Pemetrexed Disodium Carboplatin + Nab-paclitaxel + Nivolumab + Pemetrexed Disodium Carboplatin + Nivolumab + Paclitaxel + Pemetrexed Disodium Cisplatin + Nab-paclitaxel + Nivolumab + Pemetrexed Disodium + Relatlimab Cisplatin + Nivolumab + Paclitaxel + Pemetrexed Disodium + Relatlimab Carboplatin + Nab-paclitaxel + Nivolumab + Pemetrexed Disodium + Relatlimab Carboplatin + Nivolumab + Paclitaxel + Pemetrexed Disodium + Relatlimab A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) Recruiting USA | ITA | FRA | ESP | DEU | BEL | AUT 14
NCT04683250 Phase Ib/II TAS0953/HM06 Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities Recruiting USA 1
NCT04929041 Phase II Pembrolizumab Nab-paclitaxel Ipilimumab Paclitaxel Nivolumab Pemetrexed Disodium Carboplatin Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Recruiting USA 0
NCT03977194 Phase III Atezolizumab + Carboplatin + Paclitaxel Carboplatin + Paclitaxel Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Carboplatin Paclitaxel Chemotherapy (ELDERLY) Recruiting FRA 0
NCT04603807 Phase III Entrectinib Crizotinib A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Recruiting ITA | FRA | ESP 12
NCT05398094 Phase II Sotorasib Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy (MERIT-lung) Recruiting ESP 0
NCT04547504 Phase III Cisplatin + Pembrolizumab + Pemetrexed Disodium Pemetrexed Disodium Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Disodium Pembrolizumab + Pemetrexed Disodium PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 >= 50 % Recruiting FRA 0
NCT03996473 Phase Ib/II Pembrolizumab Pembrolizumab + Radium Ra 223 dichloride Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases Active, not recruiting USA | ESP | BEL 1
NCT02279433 Phase I Taletrectinib A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b Completed USA 0
NCT05358548 Phase II Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Fluorouracil + Pembrolizumab ATATcH Alternating Treatment Plans for Advanced Cancer Not yet recruiting USA 0
NCT03425006 Phase II Itacitinib + Pembrolizumab Pembrolizumab and Itacitinib (INCB039110) for NSCLC Terminated USA 0
NCT03175224 Phase Ib/II Bozitinib APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (SPARTA) Recruiting USA | ITA | FRA | ESP | CAN 9
NCT05501665 Phase Ib/II Carboplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Nab-paclitaxel + Pembrolizumab Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer Not yet recruiting USA 0
NCT03696212 Phase Ib/II Grapiprant + Pembrolizumab Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma Terminated USA 0
NCT04884282 Phase II Docetaxel + OSE 2101 Docetaxel Nivolumab + OSE 2101 Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) Recruiting ITA 0
NCT04863248 Phase II Docetaxel + Trilaciclib Docetaxel Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4) Terminated USA 0
NCT04892953 Phase II Carboplatin + Durvalumab + Paclitaxel Carboplatin + Durvalumab + Nab-paclitaxel Carboplatin + Durvalumab + Gemcitabine Durvalumab Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy Not yet recruiting USA 0
NCT03840915 Phase Ib/II Cisplatin + M7824 + Pemetrexed Disodium Docetaxel + M7824 Carboplatin + M7824 + Pemetrexed Disodium Cisplatin + Gemcitabine + M7824 Carboplatin + Gemcitabine + M7824 Carboplatin + M7824 + Nab-paclitaxel M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC) Completed USA | FRA | BEL 0
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) Active, not recruiting USA | ITA | ESP 5
NCT03965468 Phase II Carboplatin + Durvalumab + Paclitaxel Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC (CHESS) Active, not recruiting ESP 2
NCT04811001 Phase II Dacomitinib Osimertinib Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations (CAPLAND) Recruiting ITA 0
NCT03166631 Phase I BI 891065 + Ezabenlimab 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 Terminated USA 0
NCT04800822 Phase I PF-07284892 Cetuximab + Encorafenib + PF-07284892 Lorlatinib + PF-07284892 Binimetinib + PF-07284892 PF-07284892 in Participants With Advanced Solid Tumors Recruiting USA 0
NCT04585815 Phase Ib/II Axitinib + PF-06801591 + SGN-TGT Binimetinib + Encorafenib + PF-06801591 A Study of Sasanlimab With Other Therapies in People With Non-small Cell Lung Cancer Recruiting USA | CAN | BEL 3
NCT04526782 Phase II Docetaxel Binimetinib + Encorafenib ENCOrafenib With Binimetinib in bRAF NSCLC (ENCO-BRAF) Recruiting FRA 0
NCT02465060 Phase II Erdafitinib Trametinib Crizotinib Sapanisertib AZD4547 Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting USA 2
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 Active, not recruiting USA 0
NCT04921358 Phase III Docetaxel Sitravatinib + Tislelizumab Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Recruiting USA | ITA | FRA | ESP | DEU 3
NCT04005144 Phase I Binimetinib + Brigatinib Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer Recruiting USA 0
NCT04738487 Phase III Pembrolizumab Vibostolimab Vibostolimab (MK-7684) With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003) Recruiting USA | CAN 17
NCT04140500 Phase I RO7247669 Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors Recruiting USA | ESP 6
NCT03322566 Phase II Carboplatin + Paclitaxel + Pembrolizumab Epacadostat + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Disodium Pemetrexed Disodium Carboplatin + Epacadostat + Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Epacadostat + Paclitaxel + Pembrolizumab Cisplatin + Epacadostat + Pembrolizumab + Pemetrexed Disodium A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06) Completed USA | ITA | ESP | CAN 10
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) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 11
NCT04940637 Phase II Dostarlimab-gxly + Niraparib UNITO-001-A Phase II Study in HRR/PDL1 Positive MPM/NSCLC Recruiting ITA 0
NCT05118789 Phase Ib/II NUV-520 A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Recruiting USA | FRA | ESP 2
NCT02473497 Expanded access Crizotinib Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients Available USA 0
NCT04084717 Phase II Crizotinib Study of Crizotinib for ROS1 and MET Activated Lung Cancer Recruiting CAN 0
NCT05212922 Phase II Toripalimab + YH001 A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC (YH001) Not yet recruiting AUT 4
NCT03559049 Phase Ib/II Carboplatin + Pembrolizumab + Pemetrexed Disodium + Rucaparib Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer Recruiting USA 0
NCT04693468 Phase I Axitinib + Talazoparib Crizotinib + Talazoparib Palbociclib + Talazoparib Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial Recruiting USA 0
NCT03840902 Phase II Carboplatin + Paclitaxel M7824 Cisplatin + Etoposide Durvalumab Cisplatin + Etoposide + M7824 Carboplatin + M7824 + Paclitaxel Cisplatin + M7824 + Pemetrexed Disodium Cisplatin + Pemetrexed Disodium M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) Active, not recruiting USA | FRA | ESP | DEU | CAN | BEL 9
NCT04776447 Phase II Atezolizumab + Carboplatin + Paclitaxel Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO) Recruiting ESP 0
NCT03516981 Phase II MK-1308 + Pembrolizumab 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/KEYNOTE-495) Active, not recruiting USA | ITA | ESP | CAN 12
NCT03994796 Phase II Abemaciclib GDC-0084 Entrectinib Genetic Testing in Guiding Treatment for Patients With Brain Metastases Recruiting USA 0
NCT03591731 Phase II Nivolumab Ipilimumab + Nivolumab Nivolumab +/- Ipilimumab in Patients With Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs) (NIPINEC) Active, not recruiting FRA 0
NCT03793179 Phase III Carboplatin + Pembrolizumab + Pemetrexed Disodium Pembrolizumab + Pemetrexed Disodium Pembrolizumab Carboplatin + Pemetrexed Disodium Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer Recruiting USA | CAN 1
NCT04151563 Phase Ib/II Lucitanib + Nivolumab Docetaxel Cabozantinib + Nivolumab Cabozantinib + Ipilimumab + Nivolumab Docetaxel + Nivolumab Docetaxel + Nivolumab + Ramucirumab A Phase 1/2 Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV Non-small Cell Lung Cancer That Has Spread or Has Reoccurred After Failure of Chemotherapy and Immunotherapy Withdrawn USA | BEL 8
NCT05048797 Phase III Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Trastuzumab deruxtecan A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT04263051 Phase II Nivolumab + UCPVax Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer (Optim-UCPVax) Recruiting FRA 0
NCT03975114 Phase II Durvalumab + Tremelimumab Durvalumab A Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5) Recruiting ITA 0
NCT03709147 Phase II Carboplatin + Metformin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Metformin + Pembrolizumab + Pemetrexed Disodium Metformin Plus/Minus Fasting Mimicking Diet to Target the Metabolic Vulnerabilities of LKB1-inactive Lung Adenocarcinoma (FAME) Recruiting ITA 0
NCT03334617 Phase II AZD9150 + Durvalumab Durvalumab + Olaparib Cediranib + Durvalumab Durvalumab + Vistusertib Durvalumab + Trastuzumab deruxtecan Ceralasertib + Durvalumab 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 USA | FRA | ESP | DEU | CAN | AUT 2
NCT04105270 Phase II Carboplatin + Durvalumab + Pemetrexed Disodium Cisplatin + Durvalumab + Pemetrexed Disodium Durvalumab P2 of RMT in Combo w Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC Not yet recruiting USA 0
NCT04108026 Phase II Durvalumab Immunotherapy in Patient With Poor General Condition (SAVIMMUNE) Recruiting FRA 0
NCT04223596 Phase II Brigatinib Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (CUBIK) Active, not recruiting ESP 0
NCT05215340 Phase III Pembrolizumab Datopotamab Deruxtecan + Pembrolizumab Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (TROPION-Lung08) Recruiting USA | ESP 7
NCT04956692 Phase III Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86) Recruiting USA | FRA | ESP 13
NCT04292119 Phase Ib/II Binimetinib + Lorlatinib Crizotinib + Lorlatinib Lorlatinib Combinations in Lung Cancer Recruiting USA 0
NCT03088930 Phase II Crizotinib Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer Completed USA 0
NCT05313009 Phase Ib/II Sotorasib + TH-4000 Tarlox and Sotorasib in Patients With KRAS G12C Mutations Recruiting USA 0
NCT02696993 Phase Ib/II Nivolumab Ipilimumab + Nivolumab Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer Recruiting USA 0
NCT05006794 Phase I GS-9716 + Sacituzumab govitecan-hziy GS-9716 Docetaxel + GS-9716 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies Recruiting USA 0
NCT03093116 Phase Ib/II Repotrectinib A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 12
NCT03469960 Phase III Ipilimumab + Nivolumab Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr (DICIPLE) Active, not recruiting FRA 0
NCT05007769 Phase II ALT-803 + Atezolizumab + Ramucirumab Ramucirumab, Atezolizumab and N-803 After Progression on Any Immune Checkpoint Blocker in NSCLC (RAN) Withdrawn 0
NCT03915951 Phase II Binimetinib + Encorafenib An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer Active, not recruiting USA | ITA | ESP 2
NCT04832854 Phase II Atezolizumab + Carboplatin + Pemetrexed Disodium + Tiragolumab Atezolizumab + Carboplatin + Paclitaxel + Tiragolumab Atezolizumab + Tiragolumab Atezolizumab + Cisplatin + Pemetrexed Disodium + Tiragolumab Atezolizumab + Carboplatin + Gemcitabine + Tiragolumab Atezolizumab + Cisplatin + Gemcitabine + Tiragolumab Cisplatin + Gemcitabine Carboplatin + Gemcitabine Carboplatin + Paclitaxel Carboplatin + Pemetrexed Disodium Cisplatin + Pemetrexed Disodium A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer Recruiting USA | ESP 2
NCT03896074 Phase II Atezolizumab + Bevacizumab Atezolizumab Atezolizumab Versus Atezolizumab Plus Bevacizumab as First Line in NSCLC Patients (BEAT) (BEAT) Not yet recruiting ITA 0
NCT03308942 Phase II Niraparib Niraparib + Pembrolizumab Dostarlimab-gxly + Niraparib Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Completed USA 0
NCT04995523 Phase Ib/II AZD2936 A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (ARTEMIDE-01) Recruiting USA | FRA | ESP | BEL 9
NCT00585195 Phase I Crizotinib + Itraconazole Crizotinib + Rifampin A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer (PROFILE 1001) Completed USA 3
NCT02568267 Phase II Entrectinib Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2) Recruiting USA | ITA | FRA | ESP | DEU | BEL 10
NCT04827576 Phase II Docetaxel + Hu5F9-G4 Study of Magrolimab in Participants With Solid Tumors Recruiting USA | FRA | ESP 1
NCT02554812 Phase Ib/II Avelumab + PF-04518600 Avelumab + PD 0360324 Avelumab + Utomilumab Avelumab + PF-04518600 + Utomilumab A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) Active, not recruiting USA | FRA | CAN 5
NCT03708328 Phase I RO7121661 A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors Active, not recruiting USA | FRA | ESP 3
NCT04984811 Phase II Atezolizumab + NT-I7 NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC Recruiting USA 0
NCT04250246 Phase II Ipilimumab + Nivolumab Guadecitabine + Ipilimumab + Nivolumab A Study of NIVO Plus IPI and Guadecitabine or NIVO Plus IPI in Melanoma and NSCLC Resistant to Anti-PD1/PDL1 (NIBIT-ML1) Not yet recruiting ITA 0
NCT04512430 Phase II Atezolizumab + Bevacizumab + Carboplatin + Pemetrexed Disodium Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients Recruiting ESP 0
NCT05144997 FDA approved Lorlatinib Lorlatinib Continuation Study Recruiting FRA | ESP 2
NCT03993873 Phase Ib/II TPX-0022 Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET Recruiting USA | FRA | ESP 1
NCT03317496 Phase II Avelumab + Cisplatin + Gemcitabine Avelumab + Carboplatin + Pemetrexed Disodium Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies Active, not recruiting USA | ITA | ESP | CAN 4
NCT04270591 Phase Ib/II SCC244 Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer Recruiting USA 2
NCT03829319 Phase III Carboplatin + Lenvatinib + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Lenvatinib + Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006) Active, not recruiting USA | FRA | ESP | DEU | CAN 12
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 USA | ITA | FRA | ESP | DEU | CAN | AUT 10
NCT04655976 Phase II Docetaxel Cobolimab + Docetaxel + Dostarlimab-gxly Docetaxel + Dostarlimab-gxly Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants (COSTAR Lung) Recruiting USA | ITA | FRA | ESP | DEU | CAN 11
NCT01970865 Phase 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 USA | ITA | FRA | ESP | DEU | CAN | BEL 7
NCT03827850 Phase II Erdafitinib FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) Recruiting DEU 0
NCT05064280 Phase II Lenvatinib Pembrolizumab Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases Recruiting USA 0
NCT02321501 Phase I Ceritinib + Everolimus Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer Active, not recruiting USA 0
NCT04625699 Phase II Durvalumab + Tremelimumab Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment Not yet recruiting USA 0
NCT03348904 Phase III Carboplatin + Cisplatin + Gemcitabine + Nivolumab + Paclitaxel + Pemetrexed Disodium Carboplatin + Cisplatin + Gemcitabine + Paclitaxel + Pemetrexed Disodium Carboplatin + Cisplatin + Epacadostat + Gemcitabine + Nivolumab + Paclitaxel + Pemetrexed Disodium Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer Terminated USA 0
NCT03786692 Phase II Atezolizumab + Bevacizumab + Carboplatin + Pemetrexed Disodium Bevacizumab + Carboplatin + Pemetrexed Disodium Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC Recruiting USA 0
NCT05255302 Phase II Pembrolizumab + Pemetrexed Disodium Cisplatin + Paclitaxel + Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction (DIAL) Recruiting FRA 0
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 USA 0
NCT02879617 Phase II Durvalumab A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients Completed USA 0
NCT04467723 Phase Ib/II Atezolizumab + Pirfenidone Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC Not yet recruiting USA 0
NCT03904108 Phase II Ramucirumab Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy Terminated USA 0
NCT03064854 Phase I Canakinumab + Cisplatin + Pemetrexed Disodium + Spartalizumab Canakinumab + Carboplatin + Spartalizumab Carboplatin + Paclitaxel + Spartalizumab Cisplatin + Pemetrexed Disodium + Spartalizumab Cisplatin + Gemcitabine + Spartalizumab PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients Terminated USA | ITA | FRA | ESP | DEU | CAN | BEL 5