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

• Status: Not yet recruiting
• Trial end date: 2025-06-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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

-