A Phase 3 Study of Atezolizumab in Patients With Non-Small Cell Lung Cancer
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080222480
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
This phase 3 study of a PD-L1-directed antibody, atezolizumab, shows a clinically meaningful survival benefit of atezolizumab over docetaxel in previously treated patients with non-small-cell lung cancer regardless of PD-L1 expression or histology, with a favorable safety profile compared with docetaxel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1225
Locally advanced or metastatic (Stage 3B, Stage 4, or recurrent) non-small cell lung cancer (NSCLC)
Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
Measurable disease, as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Known active or untreated central nervous system (CNS) metastases
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
History of autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Active hepatitis B or hepatitis C
Prior treatment with docetaxel
Prior treatment with CD137 agonists, anti CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method