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
Overview
- Phase
- Phase 3
- Intervention
- SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
- Conditions
- Non-Small-Cell Lung Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 537
- Locations
- 7
- Primary Endpoint
- Major pathological response rate (MPR)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Treatment group A
Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
Intervention: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
Treatment group B
Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
Intervention: SHR-1316、Chemotherapeutic
Treatment group C
Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles
Intervention: Placebo、Chemotherapeutic
Outcomes
Primary Outcomes
Major pathological response rate (MPR)
Time Frame: At time of surgery
Event free survival (EFS)
Time Frame: Approximately 66 months
Secondary Outcomes
- Disease-Free Survival (DFS)(Approximately 66 months)
- Pathology complete response (pCR)(At time of surgery)
- Overall survival (OS)(Approximately 96 months)
- Objective response rate (ORR)(prior to surgery)