Идёт набор NCT06662786

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided 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: Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin.
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, Бельгия, Бразилия, Канада, Китай +17
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, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Обзор

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Вмешательства

Биопрепарат Amivantamab
Amivantamab will be administered.
Биопрепарат Cetuximab
Cetuximab will be administered.
Препарат 5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
Препарат Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Препарат Oxaliplatin
Oxaliplatin will be administered as chemotherapy regimen.
Препарат Irinotecan Hydrochloride
Irinotecan hydrochloride will be administered as chemotherapy regimen.

Первичные конечные точки

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to 4 years and 2 months]

Вторичные конечные точки (12)

Overall Survival (OS) [Срок оценки: Up to 7 Years 3 Months]
Objective Response Rate (ORR) as Assessed by BICR [Срок оценки: Up to 7 Years 3 Months]
Objective Response Rate (ORR) as Assessed by Investigator [Срок оценки: Up to 7 Years 3 Months]
Progression Free Survival (PFS) as Assessed by Investigator [Срок оценки: Up to 7 Years 3 Months]
Duration of Response (DOR) as Assessed by BICR [Срок оценки: Up to 7 Years 3 Months]
Duration of Response (DOR) as Assessed Investigator [Срок оценки: Up to 7 Years 3 Months]
Time to Response (TTR) as Assessed by BICR [Срок оценки: Up to 7 Years 3 Months]
Time to Response as Assessed by Investigator [Срок оценки: Up to 7 Years 3 Months]
Progression-free Survival After Subsequent Therapy (PFS2) [Срок оценки: Up to 7 Years 3 Months]
Disease Control Rate (DCR) as Assessed by BICR [Срок оценки: Up to 7 Years 3 Months]
Disease Control Rate (DCR) as Assessed by Investigator [Срок оценки: Up to 7 Years 3 Months]
Time to Treatment Failure [Срок оценки: Up to 7 Years 3 Months]

Критерии участия

Критерии включения

Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
Must agree to the submission of fresh tumor tissue
Have measurable disease according to RECIST v1.1
Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases
Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1

Критерии исключения

Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

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