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

Outcome

Outcome not reported

Stopped: “Study was closed early as the sponsor decided not to continue development of certain treatment combinations.”

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 Unknown — 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 — —