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A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT05690945•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 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.

Detailed 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.608 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
•\-

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

February 15, 2023

Primary Completion Date

June 1, 2029

Completion Date

December 1, 2029

Last Updated

November 18, 2025

Enrollment

606

ACTUAL participants

Conditions

Lung Cancer

Interventions

QL1706

DRUG

Tilesizumab

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Magnetic Resonance Imaging of the Lung: Oncological Applications

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer