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

• Status: Recruiting
• Trial end date: 2026-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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.