A Phase 2 Study of Atezolizumab in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080222545
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
The study demonstrated responses with atezolizumab monotherapy in patients with PD-L1-selected advanced NSCLC, with good tolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 667
Adult patients, >/= 18 years of age
Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
PD-L1-positive tumor status as determined by an IHC assay performed by a central laboratory
Measurable disease, as defined by RECIST v1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Any approved anti cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Central nervous system (CNS) disease, including treated brain metastases.
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
History of autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted.
Active hepatitis B or hepatitis C
HIV positive
Prior treatment with CD137 agonists, 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 efficacy<br>RECIST version1.1
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Observation / Inspection<br>RECIST version1.1