A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Recruiting · NCT04316364 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Placebo、ChemotherapeuticSHR-1316、ChemotherapeuticSHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
7 locations listed.
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Guangdong Provincial People's Hospital - Guangzhou, Guangdong, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- JiangSu Cancer Hospital - Nanjing, Jiangsu, China
- Zhongshan Hospital, Fudan University - Shanghai, Shanghai Municipality, China
- West China Hospital,Sichuan University - Chengdu, Sichuan, China
- ZheJiang Cancer Hospital - Hangzhou, Zhejiang, China