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

About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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. Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose; Palliative radiotherapy completed 7 days prior to first dose. Known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis during screening. Clinically significant cardiovascular or cerebrovascular disease -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
QL1706+chemotherapy
Tiselizumab+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.
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.