NCT07009457

Phase I Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Widespread Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-16
• Primary completion: 2025-09-01
• Completion: 2028-09-01
• First posted: 2025-06-06
• Last updated: 2025-07-04

Locations

1 site across 1 country: China