🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05690945
Active, not recruiting Phase 3

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

NCT05690945 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2023-02-15
Last updated
2025-11-18

Condition(s) studied

Lung Cancer

Investigational drug(s) / intervention(s)

QL1706 →Tilesizumab

QL1706: QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.

Tilesizumab: Tilesizumab will be administered by IV infusion at 200mg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.

Study 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 304 subjects in the experimental group and the control group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Be≥18 to ≤ 75 years of age at enrollment, male or female. 2. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition). 3. No EGFR sensitive mutations or ALK gene translocation alterations. 4. Capable of providing fresh or archived 2 years' tissue samples collected at post-diagnosis or non-radiation sites at diagnosis for central laboratory PD-L1 testing with TPS \< 1% . 5. Have a life expectancy of at least 3 months. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. No prior systemic therapy for advanced or metastatic NSCLC was received. Exclusion Criteria: 1. Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 drugs or drugs acting on another T cell receptor (e.g., CTLA-4 etc.), as well as immune checkpoint agonistic antibodies (e.g., anti ICOS , CD40 , CD137 , GITR , OX40 antibodies, etc.), and immune cell therapy. 2. Patients who have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose. 3. Presence or history of any active autoimmune disease, including, but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism. 4. Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose; 5. Palliative radiotherapy completed 7 days prior to first dose. 6. Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening. 7. Clinically significant cardiovascular or cerebrovascular disease \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong

More Qilu Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05690945 on ClinicalTrials.gov ↗ ← All trials in China