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Profile Name | ROS1 rearrange |
Gene Variant Detail | |
Relevant Treatment Approaches | ROS1 Inhibitor |
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 | 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 | 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 a preferred therapy for patients with advanced or metastatic ROS1 rearrangement-positive non-small cell lung cancer (NCCN.org). | detail... |
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 | 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 | 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 | 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 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | DS6051b | Phase I | Actionable | In a Phase I trial, 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 | 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... | |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04862780 | Phase Ib/II | BLU-945 | Study Targeting EGFR Resistance Mechanisms in NSCLC | Recruiting | USA | ESP | 6 |
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 |
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 |
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 |
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 |
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 |
NCT05007769 | Phase II | ALT-803 + Atezolizumab + Ramucirumab | Ramucirumab, Atezolizumab and N-803 After Progression on Any Immune Checkpoint Blocker in NSCLC (RAN) | Withdrawn | 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 |
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 | Terminated | USA | 0 |
NCT04776447 | Phase II | Atezolizumab + Carboplatin + Paclitaxel | Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO) | Recruiting | ESP | 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 |
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 |
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 |
NCT04811001 | Phase II | Dacomitinib Osimertinib | Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations (CAPLAND) | Recruiting | ITA | 0 |
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 |
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 |
NCT03425006 | Phase II | Itacitinib + Pembrolizumab | Pembrolizumab and Itacitinib (INCB039110) for NSCLC | Terminated | USA | 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 |
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 |
NCT03896074 | Phase II | Atezolizumab + Bevacizumab Atezolizumab | Atezolizumab Versus Atezolizumab Plus Bevacizumab as First Line in NSCLC Patients (BEAT) (BEAT) | Not yet recruiting | ITA | 0 |
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 |
NCT03827850 | Phase II | Erdafitinib | FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) | Recruiting | DEU | 0 |
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 |
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 | ESP | BEL | 5 |
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 | 7 |
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 | 1 |
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 |
NCT04108026 | Phase II | Durvalumab | Immunotherapy in Patient With Poor General Condition (SAVIMMUNE) | Recruiting | FRA | 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 |
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 |
NCT04084717 | Phase II | Crizotinib | Study of Crizotinib for ROS1 and MET Activated Lung Cancer | Recruiting | CAN | 0 |
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 |
NCT03904108 | Phase II | Ramucirumab | Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy | Recruiting | USA | 0 |
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 |
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 |
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 |
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 |
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 |
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 |
NCT02473497 | Expanded access | Crizotinib | Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients | Available | USA | 0 |
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 |
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 |
NCT03088930 | Phase II | Crizotinib | Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer | Completed | 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 | 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 |
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 |
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 | 11 |
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 |
NCT03994796 | Phase II | Abemaciclib GDC-0084 Entrectinib | Genetic Testing in Guiding Treatment for Patients With Brain Metastases | Recruiting | USA | 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 |
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 |
NCT04292119 | Phase Ib/II | Binimetinib + Lorlatinib Crizotinib + Lorlatinib | Lorlatinib Combinations in Lung Cancer | Recruiting | USA | 0 |
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 |
NCT05117242 | Phase II | GEN1046 + Pembrolizumab GEN1046 | Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Another Anti-cancer Therapy for Treatment of Recurrent (Non-small Cell) Lung Cancer | Recruiting | USA | ESP | 1 |
NCT04625699 | Phase II | Durvalumab + Tremelimumab | Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment | Not yet recruiting | 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 |
NCT04512430 | Phase II | Atezolizumab + Bevacizumab + Carboplatin + Pemetrexed Disodium | Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients | Recruiting | ESP | 0 |
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 |
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) | Active, not recruiting | USA | FRA | BEL | 0 |
NCT04621188 | Phase II | Lorlatinib | Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) | Recruiting | FRA | 0 |
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 |
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 |
NCT03965468 | Phase II | Carboplatin + Durvalumab + Paclitaxel | Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC (CHESS) | Recruiting | ESP | 2 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
NCT04921358 | Phase III | Docetaxel Sitravatinib + Tislelizumab | Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer | Recruiting | 2 | |
NCT04526782 | Phase II | Docetaxel Binimetinib + Encorafenib | ENCOrafenib With Binimetinib in bRAF NSCLC (ENCO-BRAF) | Recruiting | FRA | 0 |
NCT04467723 | Phase Ib/II | Atezolizumab + Pirfenidone | Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC | Not yet recruiting | USA | 0 |
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 |
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 |
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 |
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 |
NCT04655976 | Phase II | Docetaxel Docetaxel + Dostarlimab-gxly + TSR-022 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 |
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 |
NCT03915951 | Phase II | Binimetinib + Encorafenib | An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer | Recruiting | USA | ITA | ESP | 2 |
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 |
NCT04223596 | Phase II | Brigatinib | Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (CUBIK) | Recruiting | ESP | 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 | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 5 |
NCT04827576 | Phase II | Docetaxel + Hu5F9-G4 | Study of Magrolimab in Participants With Solid Tumors | Recruiting | 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 |
NCT05313009 | Phase Ib/II | Sotorasib + TH-4000 | Tarlox and Sotorasib in Patients With KRAS G12C Mutations | 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 |
NCT02279433 | Phase I | DS6051b | A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b | Completed | USA | 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 |
NCT04270591 | Phase Ib/II | SCC244 | Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer | Active, not recruiting | USA | 2 |
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 |
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 |
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 |
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 |
NCT02879617 | Phase II | Durvalumab | A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients | Active, not 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) | Not yet recruiting | FRA | 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 |
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 | 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 |
NCT04940637 | Phase II | Dostarlimab-gxly + Niraparib | UNITO-001-A Phase II Study in HRR/PDL1 Positive MPM/NSCLC | Recruiting | ITA | 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) | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | AUT | 13 |
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 |
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 |
NCT03087448 | Phase Ib/II | Ceritinib + Trametinib | Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) | Terminated | USA | 0 |