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RECRUITING
NCT05487391
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Shanghai Pulmonary Hospital, Shanghai. China

Shanghai, China