A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Non-Small-Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT04316364
- Run by
- Jiangsu HengRui Medicine Co., Ltd.
- People needed
- 537
- Starts
- 2020-07-14
- Expected to finish
- 2026-12-15
- Last updated by the study team
- 2021-11-04
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
- Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
- JiangSu Cancer Hospital — Nanjing, Jiangsu, China (enrolling)
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- West China Hospital,Sichuan University — Chengdu, Sichuan, China (enrolling)
- ZheJiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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