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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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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Primary outcome measure(s)
OS — From date of randomization until the date of death from any cause, which ever came first, assessed up to 2 years Overall Survival (OS) in the ITT population determined by the investigator
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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