Informations générales (source: ClinicalTrials.gov)

NCT06662786 En recrutement IDF
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
Interventional
  • Tumeurs colorectales
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
octobre 2024
décembre 2032
13 septembre 2025
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.
 Voir le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Saint Antoine En recrutement IDF Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU De Poitiers - 86000 - Poitiers Cedex - France En recrutement Contact (sur clinicalTrials)
CHU Nantes - 44000 - Nantes Cedex 1 - France En recrutement Contact (sur clinicalTrials)
Hopital Claude Huriez - 59000 - Lille - France En recrutement Contact (sur clinicalTrials)
Hopital Haut Leveque - 33604 - Pessac - France En recrutement Contact (sur clinicalTrials)
Hopital Prive Jean Mermoz - 69008 - Lyon - France En recrutement Contact (sur clinicalTrials)
Institut du Cancer de Montpellier - 34298 - Montpellier - France En recrutement Contact (sur clinicalTrials)
Institut Sainte Catherine - 84918 - Avignon Cedex 9 - France En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Have histologically or cytologically confirmed adenocarcinoma of the left-sided
colorectal cancer. Participants must have unresectable or metastatic disease

- Be diagnosed 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 as determined by local testing

- Must agree to the submission of fresh tumor tissue

- Have measurable disease according to RECIST v1.1

- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1


- 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 unlikely 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)
or mesenchymal epithelial transition (MET)