A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

• Status: Completed
• Trial end date: 2021-02-17
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

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

Details

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

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC

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

• Measurable disease as defined by RECIST v1.1

• Adequate hematologic and end organ function

Exclusion Criteria:

• Active or untreated central nervous system (CNS) metastasis

• 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

• 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 (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted

• Positive test for Human Immunodeficiency Virus (HIV)

• Active hepatitis B or hepatitis C

• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody

• Severe infection within 4 weeks prior to randomization

• Significant history of cardiovascular disease