MK2870-004

{ "short_title": "MK2870-004", "data_mode": "900", "data_mode_number": "000002335", "official_title": "A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy \r\n(Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous \r\nNon-small Cell Lung Cancer (NSCLC) with EGFR Mutations or Other Genomic Alterations", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "gtThird", "ctgov_number": "NCT06074588", "eudract_number": null, "general_contact_email": null, "general_contact_phone": null, "hauptpruefer_dd_name": "Dr. med. Felix Saalfeld", "description_laie_de": "Eine randomisierte, offene Phase-3-Studie von MK-2870 im Vergleich zur Chemotherapie (Docetaxel oder Pemetrexed) bei zuvor behandeltem fortgeschrittenem oder metastasiertem Nicht-kleinzelligem Lungenkrebs (NSCLC) mit EGFR-Mutationen oder anderen Genomver\u00e4nderungen.", "description_laie_en": "The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.", "description_expert_de": "Eine randomisierte, offene Phase-3-Studie von MK-2870 im Vergleich zur Chemotherapie (Docetaxel oder Pemetrexed) bei zuvor behandeltem fortgeschrittenem oder metastasiertem Nicht-kleinzelligem Lungenkrebs (NSCLC) mit EGFR-Mutationen oder anderen Genomver\u00e4nderungen.", "description_expert_en": "The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 10, "sub_cat_id": 50 }