Actively Recruiting
A Phase II, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of SHR-1826 Injection in Patients With NSCLC
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-03-19
300
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase II, open-label, multicenter clinical trial to study SHR-1826 for injection in patients with non-small cell lung cancer (NSCLC). The trial aims to evaluate the safety, tolerability, and effectiveness of SHR-1826 when used in combination with other drugs in patients with locally advanced or metastatic NSCLC. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. Participants will receive SHR-1826 through intravenous infusion every 3 weeks combined with Adebrelimab every 3 weeks and SHR-8068 every 6 weeks. Some patients may also receive Bevacizumab every 3 weeks as part of the treatment regimen. This study involves one experimental treatment arm with these drug combinations. During the study, participants will be monitored for about 2 years to assess the incidence and severity of adverse events and the overall response rate to treatment. Other outcomes tracked include duration of response, disease control rate, progression-free survival, and overall survival up to 5 years after the last participant is enrolled. Participants will undergo tumor assessments, organ function tests, and tumor tissue analysis as part of their involvement.
CONDITIONS
Brief 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...
- Participants must voluntarily agree to join and sign informed consent.
- ECOG performance score must be 0 or 1.
- Life expectancy of at least 3 months.
- Have at least one measurable tumor lesion per RECIST v1.1.
- Histologically confirmed locally advanced or metastatic NSCLC.
- Good organ function.
- Ability to provide archived or fresh tumor tissue for testing.
You will not qualify if you...
- Active central nervous system or meningeal metastases.
- History of serious heart or brain blood vessel 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 radiation within 4 weeks before first dose.
- Other cancers within 5 years before first dose.
- Unresolved side effects from previous treatments above Grade 1.
- History of immunodeficiency, including positive HIV test.
- Any other conditions increasing risk or interfering with the study as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 3- or 6-week cycles as per protocol
Participants receive SHR-1826, Adebrelimab, SHR-8068 with or without Bevacizumab by intravenous infusion in repeated cycles to treat NSCLC.
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
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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