Actively Recruiting
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2021-11-04
537
Participants Needed
7
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Previously untreated, pathologically confirmed resectable Stage II, IIIA, or selected IIIB NSCLC
- Evaluation by a thoracic surgeon confirming eligibility for R0 resection with curative intent
- Adequate tumor tissue sample blocks for central PD-L1 testing
- Measurable disease as defined by RECIST v1.1
- Adequate organ function
- Women of childbearing age without sterilization or males must agree to use contraception or abstain for at least 180 days after last study treatment dose
You will not qualify if you...
- Previous systemic anti-cancer therapy for lung cancer
- Active, known, or suspected autoimmune disease
- Other malignancies within 5 years prior to randomization
- History or suspected pneumonitis/interstitial lung disease or severe lung diseases affecting lung function tests
- Significant cardiovascular or cerebrovascular disease
- Significant hemorrhagic disease
- History of arteriovenous thrombotic events
- Known HIV infection
- Active Hepatitis B or C infection
- Allergy to monoclonal antibodies or protein drugs
- Allergy to study intervention regimens
- Pregnant or lactating women
- Known psychiatric or substance abuse disorders
- Confirmed or suspected COVID-19 infection or close contact with someone with COVID-19
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
4
JiangSu Cancer Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
5
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
6
West China Hospital,Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
7
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
V
Vivian Shi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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