A Phase III Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-paclitaxel Compared With Carboplatin + Nab-paclitaxel in Patients With Stage IV Squamous NSCLC
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080222847
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Addition of atezolizumab to Carboplatin and nab-paclitaxel provides overall survival and progression-free survival benefit in patients with metastatic squamous NSCLC whose tumors have high PD-L1 expression. The safety profile in this trial was consistent with the known safety profile of each individual treatment, and no new safety signals were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1021
18 years or older
-Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
-Histologically or cytologically confirmed, treatment-naive Stage IV 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 disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>progression-free survival, Overall survival<br><br>RECIST v1.1, Observation
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>Objective response rate<br><br>RECIST v1.1