Actively Recruiting
A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-03-19
300
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.
CONDITIONS
Official Title
A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily agree to participate and sign informed consent.
- ECOG performance score of 0-1.
- Life expectancy of at least 3 months.
- At least one measurable tumor lesion based on RECIST v1.1.
- Histologically confirmed locally advanced or metastatic NSCLC.
- Good organ function.
- Provide archived or fresh tumor tissue for testing.
You will not qualify if you...
- Active central nervous system or meningeal metastases.
- History of serious cardiovascular or cerebrovascular diseases.
- History or signs of interstitial pneumonitis.
- Severe infection within 4 weeks before first dose.
- Anti-tumor therapies within 4 weeks before first dose.
- Uncontrolled tumor-related pain.
- Received more than 30 Gy of non-thoracic radical radiation within 4 weeks before first dose.
- Other malignancies within 5 years before first dose.
- Unresolved toxicities from previous anti-tumor therapy greater than Grade 1.
- History of immunodeficiency, including positive HIV test.
- Any other condition that increases risk or interferes with study participation, per investigator judgment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
Research Team
L
Li Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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