Combination of SHR-1316 and chemotherapy for resectable lung cancer
A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer
This study tests whether adding a new antibody called SHR-1316 to standard chemotherapy can help people with early-stage lung cancer feel better and improve their treatment results.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 537 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Beijing, Beijing Municipality and 6 other locations) |
| Trial ID | NCT04316364 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with untreated, pathologically confirmed resectable Stage II, IIIA, or selected IIIB NSCLC who are eligible for surgical resection.
Not a fit: Patients with a history of previous anti-cancer therapy for lung cancer or those with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with resectable NSCLC by enhancing the effectiveness of chemotherapy.
How similar studies have performed: Other studies have shown promise in using monoclonal antibodies in combination with chemotherapy for lung cancer, indicating a potentially effective approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 6 other locations
- 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)
- ZheJiang Cancer Hospital — Hangzhou, Zhejiang, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.