drugset / Trial / NCT03337698

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

NCT03337698

Phase 1/2 Terminated 314 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

Timeline

Start
2017-12-27
Primary completion
2025-10-14
Completion
2025-11-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody Intravenous
Subject Bevacizumab Monoclonal antibody Intravenous
Subject Camonsertib Small molecule Oral
Subject Carboplatin Small molecule Intravenous
Subject Cibisatamab Monoclonal antibody Intravenous
Subject Ciforadenant Small molecule Oral
Subject Cobimetinib Small molecule Oral
Subject Docetaxel Small molecule Intravenous
Subject Evolocumab Monoclonal antibody 140 mg Subcutaneous
Subject Gemcitabine Small molecule Intravenous
Subject Ipatasertib Small molecule Oral
Subject Linagliptin Small molecule Oral
Subject Pemetrexed Small molecule Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody Intravenous
Subject Tiragolumab Monoclonal antibody
Subject Zanzalintinib Small molecule Oral
Background Tocilizumab Monoclonal antibody