Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC

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

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.

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Cancer Extensive Stage
• Intervention / Treatment: Drug: Irinotecan liposome (II) combined with adebrelimab and carboplatin; Drug: etoposide combined with adebrelimab and carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chengzhi Zhou, Doctor; Phone Number: 13560351186; Email: doctorzcz@163.com

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510120
      • Recruiting
      • Guangzhou Institute of Respiratory Disease (Responsible Party)
      • Contact: Chengzhi Zhou; Phone Number: 13560351186; Email: doctorzcz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• Active tuberculosis or a history of active tuberculosis within 48 weeks prior to screening, regardless of whether it was treated;
• Any toxicity from previous anticancer therapy, that has not resolved to grade ≤1 (according to CTCAE v5.0) prior to the first dose of the investigational drug;
• Underwent a minor surgery (including catheter placement) within 48 hours prior to the first dose of the study drug;
• Presence of uncontrolled cardiovascular symptoms or diseases;
• Hypersensitivity to the investigational drug or its excipients;
• A history of any other malignancy within 5 years prior to the first dose of the study drug, except for adequately treated non-melanoma skin cancer or in situ carcinoma;
• A history of psychiatric disorders, alcohol abuse, drug abuse, or substance misuse;
• HBsAg-positive and HBV DNA levels exceeding the upper limit of normal, or HCV-positive (HCV RNA or HCV Ab indicating acute or chronic infection); a history of HIV-positive status or acquired immunodeficiency syndrome (AIDS);
• Received any other investigational drug or participated in another interventional clinical trial within 4 weeks prior to signing the informed consent form (ICF);
• A history of allogeneic bone marrow transplantation or solid organ transplantation;
• Any other factors as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irinotecan liposome (II)+adebrelimab+carboplatin; The patient received treatment with Irinotecan liposome (II), adebrelimab, and carboplatin.	Drug: Irinotecan liposome (II) combined with adebrelimab and carboplatin; Irinotecan liposome (II) + adebrelimab + carboplatin
Other: etoposide+adebrelimab+carboplatin; The patient received treatment with etoposide, adebrelimab, and carboplatin.	Drug: etoposide combined with adebrelimab and carboplatin; etoposide + adebrelimab + carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year OS rate	The proportion of patients who are still alive after one year of treatment.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Time from start of patient's treatment to disease progression or death from any cause.	1 year
Overall survival (OS)	Time from patient randomization to patient death from any cause.	2 years
Objective response rate (ORR)	Proportion of patients whose tumor volume shrinks to a pre-specified value and who can maintain the minimum timeframe requirement, as the sum of the proportion in complete and partial remission.	1 year
Disease control rate（DCR）	Number of cases in remission (PR+CR) and stable lesions (SD) after treatment as a percentage of evaluable cases.	1 year
Duration of Response (DoR)	the time between the first time a subject in confirmed complete remission (CR) or confirmed partial remission (PR) reaches confirmed complete remission (CR) or confirmed partial remission (PR) and the time of the first disease progression or death of any cause.	1 year
AEs rate	Incidence of adverse events occurring during treatment.	3 years.

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Principal Investigator: Chengzhi Zhou, Doctor, Guangzhou Institute of Respiratory Disease (Responsible Party)

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ES-SCLC; adebrelimab; extensive stage-small cell lung cancer; Irinotecan liposome (II); zhou chengzhi
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Irinotecan; Etoposide; Carboplatin
• Other Study ID Numbers: ES-2024-209-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No