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
Who is this study for? Patients with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
West China Hospital,Sichuan University
RECRUITING
Chengdu
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
ZheJiang Cancer Hospital
RECRUITING
Hangzhou
JiangSu Cancer Hospital
RECRUITING
Nanjing
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Vivian Shi, MD
wei.shi@hengrui.com
+86 010-67166319
Time Frame
Start Date:2020-07-14
Estimated Completion Date:2026-12-15
Participants
Target number of participants:537
Treatments
Experimental: 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
Experimental: Treatment group B
Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
Placebo_comparator: Treatment group C
Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles