Combination of SHR-1316 and chemotherapy for resectable lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness and safety of the monoclonal antibody SHR-1316 combined with platinum-based chemotherapy in patients with resectable non-small cell lung cancer (NSCLC) at Stage II, IIIA, or selected IIIB. Participants will receive either SHR-1316 or a placebo alongside chemotherapy, followed by additional treatment with SHR-1316 or placebo. The study aims to assess the immunogenicity of the treatment and monitor patient outcomes over time.

Why it matters

Who can join: the full rules

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's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• JiangSu Cancer Hospital
  Nanjing, Jiangsu, China Recruiting
• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• West China Hospital,Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: YILONG WU, M.D, PhD — Guangdong Provincial People's Hospital
• Study coordinator: Vivian Shi, MD
• Email: wei.shi@hengrui.com
• Phone: +86 010-67166319

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.