Overview

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Status:
Completed
Trial end date:
2020-12-07
Target enrollment:
0
Participant gender:
All
Summary
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Albumin-Bound Paclitaxel
Antibodies
Antibodies, Monoclonal
Atezolizumab
Bevacizumab
Carboplatin
Paclitaxel
Criteria
Inclusion Criteria:

- Eastern Cooperative Oncology Group performance status 0 or 1

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

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

- Known PD-L1 status as determined by immunohistochemistry assay performed on previously
obtained archival tumor tissue or tissue obtained from a 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