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Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Summary
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.
Official title: An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-06-16
Completion Date
2028-09
Last Updated
2025-07-04
Healthy Volunteers
No
Conditions
Interventions
SHR-1316 (sc) Injection
SHR-1316 (sc) injection.
SHR-1316 Injection
SHR-1316 injection.
Carboplatin Injection
Carboplatin injection.
Etoposide Injection
Etoposide injection.
Locations (1)
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China