Идёт набор NCT06801834

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Фаза III С лечением Extensive Stage Small Cell Lung Cancer (ES-SCLC)

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: Sacituzumab Govitecan (SG), Topotecan, Amrubicin (Japan only), Lurbinectedin (regions/countries where approved and available).
Кому может быть актуально: Состояния в реестре: Extensive Stage Small Cell Lung Cancer (ES-SCLC). 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: США, Аргентина, Австралия, Бельгия, Бразилия +18
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 Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Обзор

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).

Вмешательства

Препарат Sacituzumab Govitecan (SG)
Administered intravenously
Препарат Topotecan
Administered intravenously
Препарат Amrubicin (Japan only)
Administered intravenously
Препарат Lurbinectedin (regions/countries where approved and available)
Administered intravenously

Первичные конечные точки

Overall Survival (OS) [Срок оценки: Up to 4.5 years]

Вторичные конечные точки (7)

Progression-free Survival (PFS) [Срок оценки: Up to 4.5 years]
Objective Response Rate (ORR) [Срок оценки: Up to 4.5 years]
Duration of Response (DOR) [Срок оценки: Up to 4.5 years]
Time to First Deterioration in Shortness of Breath Domain [Срок оценки: Up to 4.5 years]
Time to First Deterioration in Physical Functioning Domain [Срок оценки: Up to 4.5 years]
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Срок оценки: First dose date up to 4.5 years]
Percentage of Participants Experiencing Clinical Laboratory abnormalities [Срок оценки: First dose date up to 4.5 years]

Критерии участия

Критерии включения

Histologically confirmed diagnosis of SCLC.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.
Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.
If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.
If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.

Note: at least 85% of participants included in the study must be pretreated with anti-PD-\[L\]1 therapy.

Refer to protocol for country-specific requirements for participants in China.

Критерии исключения

Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) < 30 days (independent of the immunotherapy maintenance).
Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy.
Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 · 32 центра

Beijing Cancer Hospital — Пекин
Jilin Cancer Hospital — Changchun
Sichuan Cancer Hospital — Чэнду
Chongqing University Cancer Hospital — Чунцин
Fujian Medical University Union Hospital — Фучжоу
Sun Yat-sen University Cancer Center — Гуанчжоу
The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
Zhejiang Cancer Hospital — Ханчжоу
… и ещё 24 центра

США · 21 центр

Genesis Cancer and Blood Institute — Hot Springs
Los Angeles Cancer Network — Anaheim
Boca Raton Regional — Miami
Hope and Healing Cancer Services — Hinsdale
Southern Illinois University School of Medicine — Springfield
Springfield Clinic — Springfield
Parkview Research Center — Fort Wayne
IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie — Muncie
… и ещё 13 центров

Япония · 20 центров