drugset / Trial / NCT05487391

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.

NCT05487391

Phase 3 Recruiting 632 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-12-08
Primary completion
2027-08-31
Completion
2029-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject QL1706 Monoclonal antibody 5 mg/kg Intravenous
Background Carboplatin Small molecule Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous
Background Vinorelbine Small molecule 25 mg/m2 Intravenous