Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
632
Start Date
2022-12-08
Completion Date
2029-05-22
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
QL1706 injection
QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
Vinorelbine Tartrate
Vinorelbine 25mg/m2(D1、D8)Q3W IV, 2-4 cycles
Paclitaxel
Paclitaxel 175mg/m2(D1) Q3W IV, 2-4 cycles
Cisplatin
Cisplatin 75mg/m2(D1)Q3W IV, 2-4 cycles
Carboplatin
Carboplatin AUC=5(D1) Q3W IV, 2-4 cycles
Pemetrexed
Pemetrexed 500mg/m2(D1) Q3W IV, 2-4 cycles
Placebo
Placebo
Locations (1)
Shanghai Pulmonary Hospital, Shanghai. China
Shanghai, China