A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
Stopped early · Phase 1/Phase 2
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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).
Key facts
- Study ID
- NCT03337698
- Run by
- Hoffmann-La Roche
- People needed
- 314
- Starts
- 2017-12-27
- Expected to finish
- 2025-11-25
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Prior allogeneic stem cell or solid organ transplantation
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- History of malignancy other than NSCLC within 2 years prior to screening
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment
Where it is running
- Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley — Las Vegas, Nevada, United States
- Columbia University Medical Center — New York, New York, United States
- University Hospitals Case Medical Center — Cleveland, Ohio, United States
- SCRI Oncology Partners — Nashville, Tennessee, United States
- Blacktown Hospital — Blacktown, New South Wales, Australia
- Peter Mac Callum Cancer Center — East Melbourne, Victoria, Australia
- Centre Georges Francois Leclerc — Dijon, France
- Centre Léon Bérard — Lyon, France
- Hopital de la Timone — Marseille, France
- Institut Régional du Cancer de Montpellier — Montpellier, France
- Institut De Cancerologie De L'Ouest — Saint-Herblain, France
- Institut Universitaire du Cancer de Toulouse-Oncopole — Toulouse, France
- Rambam Medical Center — Haifa, Israel
- Rabin Medical Center — Petah Tikva, Israel
- Chaim Sheba Medical Center — Ramat Gan, Israel
- Seoul National University Hospital — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Korea University Guro Hospital — Seoul, South Korea
- University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC) — Songpa-gu, South Korea
- Clínica Universidad de Navarra — Pamplona, Navarre, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Hospital Universitario La Paz — Madrid, Spain
- Fundación Jimenez Díaz — Madrid, Spain
- Hospital Universitario HM Sanchinarro-CIOCC — Madrid, Spain
- Hospital Regional Universitario de Malaga — Málaga, Spain
Full record on ClinicalTrials.gov
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