Recruiting

Irinotecan Liposome or Etoposide with Adebrelimab and Carboplatin for ES-SCLC

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What is being tested

Irinotecan liposome (II) combined with adebrelimab and carboplatin

+ etoposide combined with adebrelimab and carboplatin

Drug
Who is being recruted

From 18 to 70 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorGuangzhou Institute of Respiratory Disease
Study ContactChengzhi Zhou, Doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2025

Actual date on which the first participant was enrolled.

The study focuses on finding a suitable treatment for patients with extensive stage small cell lung cancer (ES-SCLC), a condition where the cancer has spread significantly. The research evaluates two combinations of drugs to see which is more effective and safe as a first treatment option. One combination includes irinotecan liposome, adebrelimab, and carboplatin, while the other replaces irinotecan liposome with etoposide. The main goal is to determine which combination helps patients survive for a year or more, addressing a critical need for effective treatments in this advanced stage of lung cancer. Participants in the study receive the treatment drugs either orally or through injections, depending on the specific medication. The study is carefully designed to compare how well each drug combination works and how safe they are for patients. Researchers assess the results by looking at the overall survival rate after one year, providing important data on the potential benefits of these treatments. While the study aims to find effective treatment options, it also monitors any side effects to ensure patient safety.

Official TitleA Safety and Efficacy Evaluation Study of Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC
NCT06739928
Principal SponsorGuangzhou Institute of Respiratory Disease
Study ContactChengzhi Zhou, Doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate
Pathologically confirmed small cell lung cancer (SCLC), staged as extensive-stage SCLC (ES-SCLC) according to the VALG staging system;
No prior systemic treatment received;
At least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage SCLC;
Showing at least one target lesion (RECIST 1.1) that has not been previously irradiated;
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21 exclusion criteria prevent from participating
Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC);
Previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other DNA topoisomerase inhibitors;
Use of a strong CYP3A4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong CYP3A4 inhibitor or UGT1A1 inhibitor within 1 week prior to the first dose;
Presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The patient received treatment with Irinotecan liposome (II), adebrelimab, and carboplatin.

Group II

The patient received treatment with etoposide, adebrelimab, and carboplatin.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Guangzhou Institute of Respiratory Disease (Responsible Party)

Guangzhou, ChinaOpen Guangzhou Institute of Respiratory Disease (Responsible Party) in Google Maps
Recruiting
One Study Center