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

NCT ID: NCT05690945

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2029-12-31

Brief 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

QL1706+chemotherapy

Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive QL1706, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 or QL1706 combined with pemetrexed.

Group Type: EXPERIMENTAL

QL1706

Intervention Type: DRUG

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.

Tiselizumab+chemotherapy

Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive tiselizumab, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with tiselizumab or tiselizumab combined with pemetrexed.

Group Type: ACTIVE_COMPARATOR

Tilesizumab

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

PSB205; BGB-108

Eligibility Criteria

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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen Univeisity Cancer Center

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

QL1706-303

Identifier Type: -

Identifier Source: org_study_id