RecruitingPhase 1NCT07009457

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


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

48 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new combination of a checkpoint inhibitor drug (SHR-1316, given under the skin) plus standard chemotherapy (carboplatin and etoposide) as a first-line treatment for extensive-stage small cell lung cancer — a fast-growing form of lung cancer that has spread beyond one lung. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer confirmed by biopsy - You have not yet received chemotherapy or immunotherapy for this cancer - You are in good physical condition and have at least one measurable tumor - Your kidneys, liver, and bone marrow are working adequately **You may NOT be eligible if...** - You have previously received any systemic treatment for small cell lung cancer - Cancer has spread to the brain (or you have uncontrolled brain metastases) - You have serious autoimmune disease or are on long-term steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1316 (sc) Injection

SHR-1316 (sc) injection.

DRUGSHR-1316 Injection

SHR-1316 injection.

DRUGCarboplatin Injection

Carboplatin injection.

DRUGEtoposide Injection

Etoposide injection.


Locations(1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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NCT07009457