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

Prior treatment

• 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.
• Patients who have received systemic corticosteroids or other immunosuppressive drugs within 2 weeks prior to the first dose.
• Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose;
• Palliative radiotherapy completed 7 days prior to first dose.

Other illness

• 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.
• Clinically significant cardiovascular or cerebrovascular disease
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Other

• Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening.

• Be≥18 to ≤ 75 years of age at enrollment, male or female.
• 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).
• No EGFR sensitive mutations or ALK gene translocation alterations.
• 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% .
• Have a life expectancy of at least 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• No prior systemic therapy for advanced or metastatic NSCLC was received.