This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.
Beijing Tiantan Hospital,Capital Medical University
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Overall survival (OS)
Overall survival (OS) is defined as the time from atezolizumab initiation to death from any cause.
Time frame: Atezolizumab initiation to death from any cause (up to approximately 28 months)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by investigators according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time frame: Atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), (up to approximately 28 months)
OS Rate at 1-Year
OS rate at 1-year is defined as the probability of participants who have not experienced death from any cause at 1-year after atezolizumab initiation.
Time frame: Atezolizumab initiation to 1-year
OS Rate at 2-Year
OS rate at 2-year is defined as the probability of participants who have not experienced death from any cause at 2-year after atezolizumab initiation.
Time frame: Atezolizumab initiation to 2-year
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR), as determined by investigators according to RECIST v1.1.
Time frame: Randomization up to approximately 34 months
Duration of Response (DOR)
Duration of response (DOR) is defined as the time from the first occurrence of an objective response to disease progression or death from any cause (whichever occurs first), as determined by investigators according to RECIST v1.1.
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Beijing Chest Hospital
Beijing, China
The Third Xiangya Hospital Of Central South University
Changsha, China
Daping Hospital of Third Military Medical University
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, China
Anhui Province Cancer Hospital
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Linyishi Cancer Hospital
Linyi, China
...and 8 more locations
Time frame: Randomization up to approximately 34 months
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Time frame: Randomization up to approximately 34 months