AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

RecruitingPhase 3Ages 18 Years - 70 YearsAllJiangsu HengRui Medicine Co., Ltd.
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
  • SHR-1316、Chemotherapeutic
  • Placebo、Chemotherapeutic
📍

Where

7 sites
Beijing Cancer Hospital
Beijing, China
Guangdong Provincial People's Hospital
Guangzhou, China
Henan Cancer Hospital
Zhengzhou, China
JiangSu Cancer Hospital
Nanjing, China
Zhongshan Hospital, Fudan University
Shanghai, China
West China Hospital,Sichuan University
Chengdu, China
ZheJiang Cancer Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy