NCT04316364RecruitingPhase 3
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 537 (estimated)
- First submitted
- 19 Mar 2020
- Start date
- 14 Jul 2020
- Primary completion date
- 15 Apr 2023
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT04316364
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 537
- From 14 Jul 2020 to the primary completion date, 15 Apr 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous systematic anti-cancer therapy for lung cancer
- Malignancies other than NSCLC within 5 years prior to randomization
Other illness
- With active, known or suspected autoimmune disease of autoimmune disease
- 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 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
- 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.
Other
- Has an arteriovenous thrombotic events
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.