Shanghai Pulmonary Hospital, Shanghai. China
Shanghai, China
Location status: Recruiting
Location contact
Caicun Zhou
CONTACT
NCT Number: NCT05487391
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Shanghai, China
Location status: Recruiting
Caicun Zhou
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Up to approximately 84 months
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
Time frame: Up to approximately 108 months
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: Year 4
OS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Time frame: Year 3
DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Time frame: Year 5
DFS rates will be measured in the PD-L1 subpopulation and in the ITT population.
Time frame: Up to approximately 108 months
Assessed by Investigator
Time frame: Up to approximately 108 months
Contact information is provided by the study sponsor or research team.
Qilu Pharmaceutical Co., Ltd.
Industry
QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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