A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer [IMpower133]
- Conditions
- Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080223248
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
The addition of atezolizumab to carboplatin and etoposide was associated with significantly longer overall survival and progression-free survival among patients with ES-SCLC, and the safety profile of ACE was consistent with the defined safety risks of the individual agents.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 403
Histologically or cytologically confirmed ES-SCLC
-No prior treatment for ES-SCLC
-ECOG performance status of 0 or 1
-Measurable disease, as defined by RECIST v1.1
-Adequate hematologic and end organ function
-Active or untreated CNS metastases
-Malignancies other than SCLC within the last 5 years
-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 CT scan.
-Positive test for Human Immunodeficiency Virus (HIV)
-Active hepatitis B or hepatitis C
-Severe infections at the time of enrollment
-Significant cardiovascular disease
-Prior treatment with cluster of CD137 agonists or immune checkpoint blockade therapies, anti-PD1, and anti-PD-L1 therapeutic antibody
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method