Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
Trial Parameters
Brief Summary
This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation and written informed consent. 2. 18-75 years old, no gender limitation. 3. Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation. 4. Confirmed tumor PD-L1 status prior to randomization. 5. Eastern Cooperative Oncology Group (ECOG) score: 0-1 6. With a life expectancy ≥ 3 months. 7. At least one measurable lesion according to RECIST v1.1. Exclusion Criteria: 1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression; 2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites; 3. Previous or co-existing malignancies； 4. Have Active or prior documented autoimmune or inflammatory disorders; 5. Active hepatitis B or hepatitis C, or with a history of immunodeficiency; 6. Have an active or p