The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
632
QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
Vinorelbine 25mg/m2(D1、D8)Q3W IV, 2-4 cycles
Paclitaxel 175mg/m2(D1) Q3W IV, 2-4 cycles
Cisplatin 75mg/m2(D1)Q3W IV, 2-4 cycles
Carboplatin AUC=5(D1) Q3W IV, 2-4 cycles
Pemetrexed 500mg/m2(D1) Q3W IV, 2-4 cycles
Placebo
Shanghai Pulmonary Hospital, Shanghai. China
Shanghai, China
RECRUITINGDisease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator.
DFS was defined as the time from randomization to first recurrence of NSCLC, appearance of new primary NSCLC, or death from any cause, whichever occurred first. Tumor recurrence includes local recurrence and distant metastasis.
Time frame: Up to approximately 84 months
Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator.
Time frame: Up to approximately 84 months
Overall Survival (OS)
OS is defined as the time from random to death from any cause. OS will be measured in the PD-L1 subpopulation and in the ITT population.
Time frame: Up to approximately 108 months
Percentage of Participants Who are Survival at Year 4
OS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Time frame: Year 4
Percentage of Participants Who are Disease-Free at Year 3
DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Time frame: Year 3
Percentage of Participants Who are Disease-Free at Year 5
DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Time frame: Year 5
DFS Within Selected Populations
Assessed by Investigator
Time frame: Up to approximately 108 months
Percentage of Participants with Adverse Events and Serious Adverse Events
Time frame: Up to approximately 108 months
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