Actively Recruiting
Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-07-04
48
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the initial anti-tumor efficacy.
CONDITIONS
Official Title
Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with extensive stage small cell lung cancer confirmed by histology or cytology
- No prior first-line systemic therapy or immune checkpoint inhibitor treatment for extensive stage small cell lung cancer
- ECOG physical fitness score of 0 or 1
- At least one measurable tumor lesion according to RECIST v1.1
- Expected survival time of 12 weeks or more
- Sufficient bone marrow and organ function
- Voluntary informed consent given before trial participation
You will not qualify if you...
- Central nervous system or meningeal metastases
- Uncontrollable spinal cord compression not treatable by surgery or radiotherapy
- Uncontrollable tumor-related pain
- Symptomatic third space effusions requiring repeated drainage (pericardial, pleural, abdominal)
- Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before first investigational drug use
- Need for elective surgery during the trial period
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, or radiation pneumonitis requiring steroid treatment
- Active pneumonia or other moderate to severe lung diseases seriously affecting lung function
- Severe infections requiring hospitalization within 4 weeks before first medication
- Active infection with CTCAE grade 2 or higher requiring systemic antibiotics within 2 weeks before first medication
- Active pulmonary tuberculosis infection within the past year or untreated history of such infection
- History of immunodeficiency including HIV, other acquired or congenital immunodeficiency diseases, or organ transplant recipients
- Known alcohol or drug dependence
- Mental disorders or poor compliance
- Pregnant or lactating women
- Other serious systemic diseases or conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330200
Actively Recruiting
Research Team
R
Ran Zhao
CONTACT
R
Rongfu Mao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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