A Comparative Study of atezolizumab(MPDL3280A)With standard chemotherapy in Patients With Stage IV NSCLC
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080222849
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Atezolizumab monotherapy resulted in longer overall survival than platinum-based combination chemotherapy among patients with previously untreated metastatic NSCLC with high expression of PD-L1. Toxic effects were consistent with those that have been reported previously.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 572
Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC without any prior treatment
-Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
-Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
-Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
-Adequate hematologic and end-organ function
-Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
-Active or untreated central nervous system (CNS) metastases as determined by computed tomorgaphy (CT) or magnetic resonance imaging (MRI) evaluation
-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 PD1, and anti-PD-L1 therapeutic antibody
-Severe infection within 4 weeks prior to randomization
-Significant history of cardiovascular disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>RECIST v1.1, observation
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>other<br>safety<br>RECIST v1.1, observation, lab test, PRO