A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Phase 3
Recruiting
- Conditions
- Non-Small-Cell Lung Cancer
- Interventions
- Drug: SHR-1316、Paclitaxel (Albumin Bound)、CarboplatinDrug: SHR-1316、ChemotherapeuticDrug: Placebo、Chemotherapeutic
- Registration Number
- NCT04316364
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 537
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group A SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles Treatment group B SHR-1316、Chemotherapeutic Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles Treatment group C Placebo、Chemotherapeutic Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles
- Primary Outcome Measures
Name Time Method Major pathological response rate (MPR) At time of surgery Event free survival (EFS) Approximately 66 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
ZheJiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
JiangSu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China