Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.
Description for laymen
PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.
JSON Data
{
"short_title": "PACE-LUNG",
"data_mode": "900",
"data_mode_number": "000002233",
"official_title": "Additional Chemotherapy for EGFRm Patients With the Continued Presence of Plasma ctDNA EGFRm at Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT05281406",
"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": "PACE ist eine prospektive, multizentrische, einarmige, vom Pr\u00fcfarzt initiierte Phase-II-Studie, die den Wert einer Behandlungseskalationsstrategie durch die Hinzuf\u00fcgung einer platinbasierten Doublet-Chemotherapie zu Osimertinib bei Patienten mit behandlungsnahem NSCLC mit L858R- oder del19-EGFR-Mutation untersucht, bei denen ein schlechtes Ansprechen auf eine TKI-Einzelwirkungsbehandlung vermutet wird.",
"description_laie_en": "PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-na\u00c3\u00afve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.",
"description_expert_de": "PACE ist eine prospektive, multizentrische, einarmige, vom Pr\u00fcfarzt initiierte Phase-II-Studie, die den Wert einer Behandlungseskalationsstrategie durch die Hinzuf\u00fcgung einer platinbasierten Doublet-Chemotherapie zu Osimertinib bei Patienten mit behandlungsnahem NSCLC mit L858R- oder del19-EGFR-Mutation untersucht, bei denen ein schlechtes Ansprechen auf eine TKI-Einzelwirkungsbehandlung vermutet wird.",
"description_expert_en": "PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-na\u00c3\u00afve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "II",
"main_cat_id": 10,
"sub_cat_id": 50
}
