A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer

This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system
• Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
• Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing
• Measurable disease as defined by RECIST v1.1
• Adequate organ function
• Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment

Exclusion Criteria:

• Any previous systematic anti-cancer therapy for lung cancer
• With active, known or suspected autoimmune disease of autoimmune disease
• Malignancies other than NSCLC within 5 years prior to randomization
• Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function
• Significant history of cardiovascular and cerebrovascular disease
• Significant haemorrhagic disease
• Has an arteriovenous thrombotic events
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known active Hepatitis B or Hepatitis C
• Allergic to monoclonal antibodies or other protein drugs
• Allergic to the intervention regimens
• Pregnant or lactating women
• Has known psychiatric or substance abuse disorders
• Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.