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

NCT06739928 | Recruiting Phase 2

• 1 other identifier: ES-2024-209-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

ES-SCLC; extensive stage-small cell lung cancer; adebrelimab; Irinotecan liposome (II); zhou chengzhi

Outcome Measures

Primary Outcomes (1)

• 1-year OS rate

  The proportion of patients who are still alive after one year of treatment.

  1 year

Secondary Outcomes (6)

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  2 years

• Objective response rate (ORR)

  1 year

• Disease control rate（DCR）

  1 year

• Duration of Response (DoR)

  1 year

Study Arms (2)

Irinotecan liposome (II)+adebrelimab+carboplatin

EXPERIMENTAL

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

Drug: Irinotecan liposome (II) combined with adebrelimab and carboplatin

etoposide+adebrelimab+carboplatin

OTHER

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

Drug: etoposide combined with adebrelimab and carboplatin

Interventions

Irinotecan liposome (II) combined with adebrelimab and carboplatin DRUG

Irinotecan liposome (II) + adebrelimab + carboplatin

Irinotecan liposome (II)+adebrelimab+carboplatin

etoposide combined with adebrelimab and carboplatin DRUG

etoposide + adebrelimab + carboplatin

etoposide+adebrelimab+carboplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease (Responsible Party)

Guangzhou, Guangzhou, 510120, China

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Chengzhi Zhou, Doctor

  Guangzhou Institute of Respiratory Disease (Responsible Party)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengzhi Zhou, Doctor

CONTACT

13560351186; doctorzcz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

CN (1)