Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT07009457
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: