Actively Recruiting
A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-04-17
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of SHR-1826, an injectable drug, along with other anti-cancer treatments in adults with non-small cell lung cancer (NSCLC). This is an open-label, multi-center, Phase IB/II clinical trial aimed at finding the recommended dose for Phase II and assessing how well the treatment works in this patient group. Participants will receive SHR-1826 injections combined with other antitumor therapies, including drugs like SHR-1316, SHR-9839, SHR-8068, Ametinib mesylate, BP-102, and Carboplatin. The study observes multiple doses over an average of one year, with treatment monitoring for safety and response. During the trial, participants will undergo evaluations including tumor tissue collection, imaging to measure lesions, and blood tests to monitor drug levels and immune response. Researchers will track adverse events, tumor response rates, disease control, progression-free survival, and overall survival for about one year. Safety and drug concentration will also be closely followed throughout the study period.
CONDITIONS
Brief Title
A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation and written informed consent.
- Age between 18 and 75 years, any gender.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Life expectancy of at least 3 months.
- Pathological diagnosis of non-small cell lung cancer.
- Ability to provide fresh or archived tumor tissue.
- At least one measurable lesion by RECIST v1.1 criteria.
- Adequate organ function.
- Women of childbearing age must have a negative pregnancy test within 7 days before first dose and agree to use contraception during the trial.
You will not qualify if you...
- History or symptoms of meningeal or central nervous system metastasis.
- Previous or co-existing malignancies.
- Untreated spinal cord compression.
- Uncontrollable tumor-related pain.
- Major surgery other than biopsy within 28 days before first dose; minor surgery within 7 days before first dose.
- Use of other investigational drugs within 4 weeks before study treatment.
- Unresolved toxicities greater than grade 2 from prior cancer therapy.
- Poorly controlled or severe cardiovascular disease.
- Active hepatitis B or C infection.
- History of immunodeficiency.
- Severe infection within 30 days before first dose.
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.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive SHR-1826 in combination with other anti-cancer therapies for non-small cell lung cancer.
Visits occur periodically during treatment to monitor safety and efficacy
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Y
Yijun Jia
T
Tingting Lei
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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