Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
The primary objective of this phase IIb/III study is to evaluate whether the combinationof lurbinectedin plus doxorubicin given as first line treatment for metastaticleiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent ReviewCommittee (IRC) when compared to doxorubicin administered as a single agent.
Description for laymen
The primary objective of this phase IIb/III study is to evaluate whether the combinationof lurbinectedin plus doxorubicin given as first line treatment for metastaticleiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent ReviewCommittee (IRC) when compared to doxorubicin administered as a single agent.
JSON Data
{
"short_title": "PM1183-C-010-22 SaLuDo",
"data_mode": "900",
"data_mode_number": "000002368",
"official_title": "Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT06088290",
"eudract_number": null,
"general_contact_email": null,
"general_contact_phone": null,
"hauptpruefer_dd_name": "Dr. med. Stephan Richter",
"description_laie_de": "Das Hauptziel dieser Phase-IIb/III-Studie besteht darin, zu untersuchen, ob die Kombination von Lurbinectedin plus Doxorubicin als Erstlinienbehandlung des metastasierten Myomyosarkoms (LMS) das progressionsfreie \u00dcberleben (PFS) im Vergleich zu Doxorubicin als Einzelwirkstoff verl\u00e4ngert.",
"description_laie_en": "The primary objective of this phase IIb/III study is to evaluate whether the combinationof lurbinectedin plus doxorubicin given as first line treatment for metastaticleiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent ReviewCommittee (IRC) when compared to doxorubicin administered as a single agent.",
"description_expert_de": "Das Hauptziel dieser Phase-IIb/III-Studie besteht darin, zu untersuchen, ob die Kombination von Lurbinectedin plus Doxorubicin als Erstlinienbehandlung des metastasierten Myomyosarkoms (LMS) das progressionsfreie \u00dcberleben (PFS) im Vergleich zu Doxorubicin als Einzelwirkstoff verl\u00e4ngert.",
"description_expert_en": "The primary objective of this phase IIb/III study is to evaluate whether the combinationof lurbinectedin plus doxorubicin given as first line treatment for metastaticleiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent ReviewCommittee (IRC) when compared to doxorubicin administered as a single agent.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "II_III",
"main_cat_id": 9,
"sub_cat_id": 43
}
