Идёт набор NCT06750094

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

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, Bevacizumab, 5-fluorouracil.
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, Австралия, Бельгия, Бразилия, Китай +21
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 + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

Обзор

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

Вмешательства

Биопрепарат Amivantamab
Amivantamab will be administered.
Биопрепарат Cetuximab
Cetuximab will be administered.
Биопрепарат Bevacizumab
Bevacizumab 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 Irinotecan
Irinotecan 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 2 years 1 month]
Overall Survival (OS) [Срок оценки: Up to 4 years 4 months]

Вторичные конечные точки (12)

Objective Response Rate (ORR) as Assessed by BICR [Срок оценки: Up to 4 years 4 months]
ORR as Assessed by Investigator [Срок оценки: Up to 4 years 4 months]
Progression Free Survival as Assessed by Investigator [Срок оценки: Up to 4 years 4 months]
Duration of Response (DoR) as Assessed by BICR [Срок оценки: Up to 4 years 4 months]
Duration of Response as Assessed by Investigator [Срок оценки: Up to 4 years 4 months]
Time to Response (TTR) as Assessed by BICR [Срок оценки: Up to 4 years 4 months]
TTR as Assessed by Investigator [Срок оценки: Up to 4 years 4 months]
Progression Free Survival After Subsequent Therapy (PFS2) [Срок оценки: Up to 4 years 4 months]
Disease Control Rate (DCR) as Assessed by BICR [Срок оценки: Up to 4 years 4 months]
Disease Control Rate as Assessed by Investigator [Срок оценки: Up to 4 years 4 months]
Time to Treatment Failure [Срок оценки: Up to 4 years 4 months]
Curative Resection (R0) Rate [Срок оценки: Up to 4 years 4 months]

Критерии участия

Критерии включения

Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy

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: amivantamab, cetuximab or bevacizumab or 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 who has not received immunotherapy treatments
Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

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