A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC

Официальное название

A Randomized, Double-blind, Placebo-controlled, Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment of Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)

Обзор

This trial is a randomized, double-blind, placebo-controlled multicenter phase III clinical study aiming to evaluate the efficacy and safety of LBL-024 compared with placebo in combination with etoposide and cisplatin or carboplatin (EP or EC) for the first-line treatment of advanced EP-NEC patients.

Подробное описание

A total of 280 patients with advanced EP-NEC without systemic treatment will be enrolled in this study. Eligible patients will be randomly assigned to the experimental group or control group at a ratio of 1:1.

Вмешательства

• Препарат LBL-024 for Injection
  Intravenous infusion
• Препарат Etoposide injection
  Intravenous infusion
• Препарат Cisplatin injection
  Intravenous infusion
• Препарат Carboplatin injection
  Intravenous infusion
• Препарат LBL-024 placebo for injection
  Intravenous infusion

Первичные конечные точки

• Overall survival (OS) [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Вторичные конечные точки (8)

• Objective Response Rate (ORR) [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Disease Control Rate(DCR） [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Duration of Response(DOR） [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Progression-free Survival(PFS) [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Occurrence of adverse event (AE) and serious adverse event (SAE) [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Cmax [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Tmax [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Immunogenicity [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Критерии участия

Критерии включения

• Agrees to follow the investigational treatment protocol, visit schedule and laboratory test, comply with other requirements of the protocol, voluntarily enroll, and sign a written informed consent.
• Age ≥ 18 years (inclusive) at the time of signing informed consent.
• The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
• expected survival time of at least 12 weeks.
• According to RECIST 1.1, participants were required to have at least one measurable lesion.
• Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.

Критерии исключения

• Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
• Major surgery (other than aspiration biopsy) within 28 days prior to the first dose of study drug or significant trauma,or required to undergo scheduled surgery during the trial.
• Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
• Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
• serious cardiac and cerebrovascular disorder.
• History of immunodeficiency including HIV antibody test positive.
• patients with active hepatitis B or C.
• Women during pregnancy or lactation.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 17 центров

• Beijing GoBroad Hospital — Пекин
• Beijing Cancer Hospital — Пекин
• Fujian Cancer Hospital — Фучжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• The First Affiliated Hospital,Sun Yat-sen University — Гуанчжоу
• Guangxi Medical University Cancer Hospital — Nanning
• Harbin Medical University Cancer Hospital — Харбин
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang
• … и ещё 9 центров

Идентификаторы

NCT: NCT07720193 · LBL-024-CN301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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