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Sponsor: Hoffmann-La Roche
Conditions: Carcinoma, Non-Small-Cell Lung
Interventions: Atezolizumab, Cobimetinib, RO6958688, Docetaxel, CPI-444
Countries: United States, Australia, France, Israel, South Korea, Spain, United Kingdom
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).
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
General Inclusion Criteria * Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1 * Life expectancy greater than or equal to 3 months * Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC) * Measurable disease (at least one target lesion) * Adequate hematologic and end-organ function * Tumor accessible for biopsy * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm Inclusion Criteria for Cohort 1 * No prior systemic therapy for metastatic NSCLC * High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs \>= 50% or TC3 Inclusion Criteria for Cohort 2 \- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC Exclusion Criteria * 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
- Las Vegas, Nevada, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Blacktown, New South Wales, Australia
- East Melbourne, Victoria, Australia
- Dijon, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Saint-Herblain, France
- Toulouse, France
- Haifa, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Songpa-gu, South Korea
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Madrid, Spain
- Madrid, Spain
- Málaga, Spain
- Valencia, Spain
- London, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Sutton, United Kingdom