The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy in PD-L1 negative, locally advanced or metastatic Non-small Cell Lung Cancer Patients. The subjects were randomly divided into two groups according to 1:1, with about 304 subjects in the experimental group and the control group.
This study was a randomized, double-blind, active-controlled, multicenter Phase 3 clinical study. The study is designed to evaluate the efficacy and safety of QL1706 in combination with chemotherapy or commercial PD1 in combination with chemotherapy in locally advanced or metastatic NSCLC patients who are PD-L1 negative.608 patients would be enrolled . Subjects will be assigned randomly in a 1:1 ratio to experimental group and control group. Subjects will be stratified by pathological type: squamous cell carcinoma versus non-squamous cell carcinoma; brain metastasis: present versus absent; gender: male versus female. After randomization, subjects will be treated according to the randomization results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
606
QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.
Tilesizumab will be administered by IV infusion at 200mg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
OS
Overall Survival (OS) in the ITT population determined by the investigator
Time frame: From date of randomization until the date of death from any cause, which ever came first, assessed up to 2 years
ORR
Objective Response Rate assessed by investigator according to RECIST v1.1 criteria
Time frame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
DOR
Duration of Response assessed by investigator according to RECIST v1.1 criteria
Time frame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
DCR
Disease Control Rate assessed by investigator according to RECIST v1.1 criteria
Time frame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
PFS
Progression Free Survival in the intent to treat (ITT) population, as determined by the investigator according to RECIST v1.1 criteria
Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 2 years)
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