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.

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 632 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	QL1706 injection	QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
DRUG	Vinorelbine Tartrate	Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles
DRUG	Paclitaxel	Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles
DRUG	Cisplatin	Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles
DRUG	Carboplatin	Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles
DRUG	Pemetrexed	Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-12-08
• Primary completion: 2027-08-31
• Completion: 2029-05-22
• First posted: 2022-08-04
• Last updated: 2024-10-15

Locations

1 site across 1 country: China