Идёт набор NCT05253651

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Фаза III С лечением Colorectal Neoplasms

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: tucatinib, trastuzumab, bevacizumab, cetuximab.
Кому может быть актуально: Состояния в реестре: Colorectal Neoplasms. 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, Австрия, Бельгия +20
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

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

Обзор

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Вмешательства

Препарат tucatinib
300mg given by mouth (orally) twice daily
Препарат trastuzumab
8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.
Препарат bevacizumab
5mg/kg given by IV every 2 weeks
Препарат cetuximab
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly
Препарат oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
Препарат leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
Препарат levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
Препарат fluorouracil
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.

Первичные конечные точки

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (12)

Overall survival (OS) [Срок оценки: Up to approximately 6 years]
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR [Срок оценки: Up to approximately 3 years]
PFS per RECIST v1.1 by investigator assessment [Срок оценки: Up to approximately 3 years]
cORR per RECIST v1.1 by investigator assessment [Срок оценки: Up to approximately 3 years]
Duration of response (DOR) per RECIST v1.1 by BICR [Срок оценки: Up to approximately 3 years]
DOR per RECIST v1.1 by investigator assessment [Срок оценки: Up to approximately 3 years]
Time to second progression or death (PFS2) [Срок оценки: Up to approximately 3 years]
Incidence of adverse events (AEs) [Срок оценки: Through 30 days after the last study treatment; approximately 1 year]
Incidence of dose alterations [Срок оценки: Through 30 days after the last study treatment; approximately 1 year]
Trough concentration (Ctrough) [Срок оценки: Approximately 4 months]
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score [Срок оценки: Through 30-37 days after the last study treatment; approximately 1 year]
Time to meaningful change in EORTC QLQ30 score [Срок оценки: Through 30-37 days after the last study treatment; approximately 1 year]

Критерии участия

Критерии включения

Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory

If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
HER2+ disease as determined by a tissue based assay performed at a central laboratory.
Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
Radiographically measurable disease per RECIST v1.1 with:

At least one site of disease that is measurable and that has not been previously irradiated, or
If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:

No evidence of brain metastases
Previously treated brain metastases which are asymptomatic

Критерии исключения

Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.

Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
Previous treatment with anti-HER2 therapy
Ongoing Grade 3 or higher neuropathy
Active or untreated gastrointestinal (GI) perforation at the time of screening.

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