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RECRUITING
NCT07009457
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

SHR-1316 (sc) Injection

SHR-1316 (sc) injection.

DRUG

SHR-1316 Injection

SHR-1316 injection.

DRUG

Carboplatin Injection

Carboplatin injection.

DRUG

Etoposide Injection

Etoposide injection.

Locations (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China