A Phase III Study of Atezolizumab in Combination With Carboplatin + Paclitaxel With or Without Bevacizumab in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080222890
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD
- Brief Summary
The addition of atezolizumab to bevacizumab plus chemotherapy significantly improved progression-free survival and overall survival among patients with metastatic nonsquamous NSCLC, and the safety profile of ABCP was consistent with previously reported safety risks of the individual medicines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1202
18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naive Stage IV non-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
- 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 CD137 agonists or immune checkpoint blockade therapies, anti PD-1, and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular diseas
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>Progression-free survival (RECIST v1.1), overall survival
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>confirmatory<br>pharmacokinetics<br>Objective response rate, etc.