Status:
RECRUITING
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
537 Patients enrolled
Trial Details
Trial ID
NCT04316364
Start Date
July 14 2020
End Date
December 15 2026
Last Update
November 4 2021
Active Locations (7)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100000
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
4
JiangSu Cancer Hospital
Nanjing, Jiangsu, China, 210009