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

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.

Trial Details

NCT ID
NCT04316364
Phase
PHASE3
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
  • SHR-1316、Chemotherapeutic
  • Placebo、Chemotherapeutic
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Nanjing, Jiangsu, China|32.06167,118.77778
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility 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 o…
  • 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

For full eligibility, visit ClinicalTrials.gov.

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