A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2021-01-18
• Target enrollment: 0
• Participant gender: All

Summary

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Atezolizumab; Carboplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Histologically or cytologically confirmed, Stage IV non-squamous NSCLC

• Participants with no prior treatment for Stage IV non-squamous NSCLC

• Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening

• Measurable disease, as defined by RECIST v1.1

• Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

• Active or untreated central nervous system metastases

• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

General Medical Exclusions:

• Pregnant or lactating women

• History of autoimmune disease

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted

• Positive test for human immunodeficiency virus

• Active hepatitis B or hepatitis C

• Severe infection within 4 weeks prior to randomization

• Significant cardiovascular disease

• Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies