PM1183-C-010-22 SaLuDo

{ "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 }