OrigAMI-2

The purpose of this study is to compare how long the participants are disease-free(progression-free survival) when treated with amivantamab and chemotherapy with5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin(mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, andirinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adultparticipants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RASviral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF)wild type (WT) unresectable or metastatic left-sided colorectal cancer.

{ "short_title": "OrigAMI-2 ", "data_mode": "900", "data_mode_number": "000002395", "official_title": "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", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "first", "ctgov_number": "NCT06662786", "eudract_number": null, "general_contact_email": "oncostudy@ukdd.de", "general_contact_phone": "+49 351-4587666", "hauptpruefer_dd_name": "Prof. Dr. med. Gunnar Folprecht", "description_laie_de": "In dieser Studie soll verglichen werden, wie lange die Teilnehmer krankheitsfrei (progressionsfreies \u00dcberleben) sind, wenn sie mit Amivantamab und einer Chemotherapie mit 5-Fluorouracil, Leucovorin-Calcium (Folins\u00e4ure) oder Levoleucovorin, Oxaliplatin (mFOLFOX6) oder 5-Fluorouracil, Leucovorin-Calcium (Folins\u00e4ure) oder Levoleucovorin behandelt werden, Andirinotecan-Hydrochlorid (FOLFIRI) im Vergleich zu Cetuximab und mFOLFOX6 oder FOLFIRI bei erwachsenen Teilnehmern mit Kirsten-Ratten-Sarkom-Virus-Onkogen-Homolog (KRAS)/Neuroblastom-RAS-Virus-Onkogen-Homolog (NRAS) und v-Raf-Maus-Sarkom-Virus-Onkogen-Homolog B1 (BRAF)-Wildtyp (WT) inoperablem oder metastasierendem linksseitigem kolorektalem Krebs.", "description_laie_en": "The purpose of this study is to compare how long the participants are disease-free(progression-free survival) when treated with amivantamab and chemotherapy with5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin(mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, andirinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adultparticipants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RASviral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF)wild type (WT) unresectable or metastatic left-sided colorectal cancer.", "description_expert_de": "In dieser Studie soll verglichen werden, wie lange die Teilnehmer krankheitsfrei (progressionsfreies \u00dcberleben) sind, wenn sie mit Amivantamab und einer Chemotherapie mit 5-Fluorouracil, Leucovorin-Calcium (Folins\u00e4ure) oder Levoleucovorin, Oxaliplatin (mFOLFOX6) oder 5-Fluorouracil, Leucovorin-Calcium (Folins\u00e4ure) oder Levoleucovorin behandelt werden, Andirinotecan-Hydrochlorid (FOLFIRI) im Vergleich zu Cetuximab und mFOLFOX6 oder FOLFIRI bei erwachsenen Teilnehmern mit Kirsten-Ratten-Sarkom-Virus-Onkogen-Homolog (KRAS)/Neuroblastom-RAS-Virus-Onkogen-Homolog (NRAS) und v-Raf-Maus-Sarkom-Virus-Onkogen-Homolog B1 (BRAF)-Wildtyp (WT) inoperablem oder metastasierendem linksseitigem kolorektalem Krebs.", "description_expert_en": "The purpose of this study is to compare how long the participants are disease-free(progression-free survival) when treated with amivantamab and chemotherapy with5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin(mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, andirinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adultparticipants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RASviral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF)wild type (WT) unresectable or metastatic left-sided colorectal cancer.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 2, "sub_cat_id": 6 }