A Safety and Efficacy Evaluation Study of Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC

Guangzhou Institute of Respiratory Disease1 site in 1 country120 target enrollmentJanuary 1, 2025

ConditionsSmall Cell Lung Cancer Extensive Stage

InterventionsIrinotecan liposome (II) combined with adebrelimab and carboplatin etoposide combined with adebrelimab and carboplatin

DrugsIrinotecan liposome (II) combined with adebrelimab and carboplatin etoposide combined with adebrelimab and carboplatin

Overview

Phase: Phase 2
Intervention: Irinotecan liposome (II) combined with adebrelimab and carboplatin
Conditions: Small Cell Lung Cancer Extensive Stage
Sponsor: Guangzhou Institute of Respiratory Disease
Enrollment: 120
Locations: 1
Primary Endpoint: 1-year OS rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.

Registry

clinicaltrials.gov

Start Date

January 1, 2025

End Date

December 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangzhou Institute of Respiratory Disease

Responsible Party

Principal Investigator

Zhou Chengzhi

doctor

Guangzhou Institute of Respiratory Disease

Eligibility Criteria

Inclusion Criteria

•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;
•Male or female patients aged ≥18 and ≤70 years;
•ECOG performance status (PS) score of 0 or 1;
•Life expectancy of ≥12 weeks;
•Adequate organ function: (1) Hematologic: WBC ≥ 3.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 9.0 g/dL.(2) Hepatic function: AST ≤ 2.5 × ULN, ALT ≤ 2.5 × ULN, liver metastases allowed if ALT and AST ≤ 5 × ULN, TBIL ≤ 1.5 × ULN (except for Gilbert's syndrome, where total bilirubin ≤ 3.0 mg/dL),(3) Renal function: Cr ≤ 1.5 × ULN or CrCl ≥ 50 mL/min, (4) Coagulation: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
•Agreement to use an appropriate contraceptive method from the first dose of the study treatment until 6 months after the last dose of the study treatment. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment;
•The patient must have fully understood the study and voluntarily consent to participate by signing the informed consent form (ICF).

Exclusion Criteria

•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;
•Hematologic disorders, including but not limited to lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome, etc;
•Clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, or ascites that cannot be controlled by drainage or other treatments;
•Active, known, or suspected autoimmune disease;
•Use of corticosteroids (doses\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study drug;
•Receipt of live vaccines or planned vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug;
•Interstitial lung disease, drug-induced pneumonia, radiation-induced pneumonia requiring steroid treatment, or clinically symptomatic active pneumonia, or severe pulmonary dysfunction;