Trial Type
Follow-Up Treatment (Metastatic Disease)
Description for experts
The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR)
Description for laymen
The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR)
JSON Data
{
"short_title": "Amgen 20230153 ",
"data_mode": "900",
"data_mode_number": "000002445",
"official_title": "A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 \r\nin Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC).",
"accrual_state": "planned",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "gtThird",
"ctgov_number": "NCT06593522",
"eudract_number": "2024-514459-14",
"general_contact_email": "ectu@ukdd.de",
"general_contact_phone": "+49 351-4587566",
"hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke",
"description_laie_de": "Das Hauptziel der Studie ist die Charakterisierung der Sicherheit und Wirksamkeit von 2 Dosisstufen von AMG 193 durch den Pr\u00fcfarzt und die Bewertung der Wirksamkeit von AMG 193 als Monotherapie durch eine verblindete unabh\u00e4ngige zentrale \u00dcberpr\u00fcfung (BICR).",
"description_laie_en": "The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR)",
"description_expert_de": "Das Hauptziel der Studie ist die Charakterisierung der Sicherheit und Wirksamkeit von 2 Dosisstufen von AMG 193 durch den Pr\u00fcfarzt und die Bewertung der Wirksamkeit von AMG 193 als Monotherapie durch eine verblindete unabh\u00e4ngige zentrale \u00dcberpr\u00fcfung (BICR).",
"description_expert_en": "The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR)",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "II",
"main_cat_id": 10,
"sub_cat_id": 50
}
