Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Trilaciclib, Placebo, Topotecan.
- Кому может быть актуально
- Состояния в реестре: Extensive-stage Small-cell Lung Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
Обзор
This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
Подробное описание
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.
Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
Вмешательства
- Препарат Trilaciclib
Participants will receive intravenous trilaciclib infusion - Препарат Placebo
Participants will receive intravenous placebo infusion - Препарат Topotecan
Participants will receive intravenous topotecan infusion
Первичные конечные точки
- Overall survival (OS) [Срок оценки: From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months]
Вторичные конечные точки (12)
- Anti-tumor efficacy [Срок оценки: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months]
- Anti-tumor efficacy [Срок оценки: From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months]
- Anti-tumor efficacy [Срок оценки: From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months]
- Neutrophil-related myeloprotection efficacy [Срок оценки: From date of randomization until end of cycle 1 (each cycle is 21 days)]
- Neutrophil-related myeloprotection efficacy [Срок оценки: From date of randomization until end of treatment, assessed up to 52 months]
- Neutrophil-related myeloprotection efficacy [Срок оценки: From date of randomization until end of treatment, assessed up to 52 months]
- RBC related myeloprotection efficacy [Срок оценки: From date of randomization until end of treatment, assessed up to 52 months]
- RBC related myeloprotection efficacy [Срок оценки: From date of randomization until end of Week 5]
- RBC related myeloprotection efficacy [Срок оценки: From date of randomization until end of Week 5]
- Platelet related myeloprotection efficacy [Срок оценки: From date of randomization until end of treatment, assessed up to 52 months]
- Platelet related myeloprotection efficacy [Срок оценки: From date of randomization until end of treatment, assessed up to 52 months]
- Myeloprotection efficacy [Срок оценки: From date of randomization until end of treatment, assessed up to 52 months]
Критерии участия
Критерии включения
- ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
- Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
- Measurable or evaluable disease as defined by RECIST v1.1
Критерии исключения
- History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
- Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer
- Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
- Radiotherapy within 2 weeks
- History of ILD/pneumonitis
- History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- Hospital — Seville
Идентификаторы
NCT: NCT05874401 · G1T28-211 · 2022-502357-34-00