Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naive ROS1-positive non-small cell lung cancer (NSCLC).
Description for laymen
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naive ROS1-positive non-small cell lung cancer (NSCLC).
JSON Data
{
"short_title": "CA127-1030 (TRIDENT-3)",
"data_mode": "900",
"data_mode_number": "000002316",
"official_title": "Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naive ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT06140836",
"eudract_number": null,
"general_contact_email": "oncostudy@ukdd.de",
"general_contact_phone": "+49 351-4587666",
"hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke",
"description_laie_de": "Ziel dieser Studie ist es, die Wirksamkeit und Sicherheit von Repotrectinib und Crizotinib bei Teilnehmern mit lokal fortgeschrittenem oder metastasiertem TKI-naivem ROS1-positivem nicht-kleinzelligem Lungenkrebs (NSCLC) zu untersuchen.",
"description_laie_en": "The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naive ROS1-positive non-small cell lung cancer (NSCLC).",
"description_expert_de": "Ziel dieser Studie ist es, die Wirksamkeit und Sicherheit von Repotrectinib und Crizotinib bei Teilnehmern mit lokal fortgeschrittenem oder metastasiertem TKI-naivem ROS1-positivem nicht-kleinzelligem Lungenkrebs (NSCLC) zu untersuchen.",
"description_expert_en": "The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naive ROS1-positive non-small cell lung cancer (NSCLC).",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 10,
"sub_cat_id": 50
}
