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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

NCT07009457 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2025-09-30
Completion
2028-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07009457 on ClinicalTrials.gov