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A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:
A Randomized, Double-blind, Multicenter Phase 3 Clinical Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Chemotherapy in First-line PD-L1 Negative, Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy in PD-L1 negative, locally advanced or metastatic Non-small Cell Lung Cancer Patients. The subjects were randomly divided into two groups according to 1:1, with about 325 subjects in the experimental group and the control group.

Clinical Trial Description

This study was a randomized, double-blind, active-controlled, multicenter Phase 3 clinical study. The study is designed to evaluate the efficacy and safety of QL1706 in combination with chemotherapy or commercial PD1 in combination with chemotherapy in locally advanced or metastatic NSCLC patients who are PD-L1 negative.650 patients would be enrolled . Subjects will be assigned randomly in a 1:1 ratio to experimental group and control group. Subjects will be stratified by pathological type: squamous cell carcinoma versus non-squamous cell carcinoma; brain metastasis: present versus absent; gender: male versus female. After randomization, subjects will be treated according to the randomization results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05690945
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact Lianghua Fang
Phone 86-13645192882
Email lianghua.fang@qilu-pharma.com
Status Not yet recruiting
Phase Phase 3
Start date February 1, 2023
Completion date June 23, 2025
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