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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Irinotecan liposome (II) combined with adebrelimab and carboplatin
  Irinotecan liposome (II) + adebrelimab + carboplatin
• Препарат etoposide combined with adebrelimab and carboplatin
  etoposide + adebrelimab + carboplatin

Первичные конечные точки

• 1-year OS rate [Срок оценки: 1 year]

Вторичные конечные точки (6)

• Progression-free survival (PFS) [Срок оценки: 1 year]
• Overall survival (OS) [Срок оценки: 2 years]
• Objective response rate (ORR) [Срок оценки: 1 year]
• Disease control rate（DCR） [Срок оценки: 1 year]
• Duration of Response (DoR) [Срок оценки: 1 year]
• AEs rate [Срок оценки: 3 years.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangzhou Institute of Respiratory Disease (Responsible Party) — Гуанчжоу

Идентификаторы

NCT: NCT06739928 · ES-2024-209-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗