Spots Global Cancer Trial Database for DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors
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Trial Identification
Brief Title: DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors
Official Title: Phase II Clinical Trial of Neo-adjuvant Chemo/Immunotherapy Followed by Adjuvant Treatment Depending on the Resection Status for the Treatment of NSCLC Patients Diagnosed With Pancoast Tumor. A Multicenter Exploratory Study
Study ID: NCT05684276
Study Description
Brief Summary: The goal of this clinical trial is to test the efficacy of induction treatment of immunotherapy and chemotherapy depending on the resection status for the treatment of non small cell lung cancer patients diagnosed with pancoast tumor. The main objectives it aims to answer are: * Complete resection rate after induction treatment with chemotherapy plus nivolumab * Overall Survival and Progression Free Survival at 24 months The sample size is 40 patients.
Detailed Description: This is an open-label, phase II, single-arm, multi-centre clinical trial. The total sample size is 40 patients. The population to be included are previously untreated patients with histologically- or cytologically- documented NSCLC diagnosed with Pancoast tumor. Patients will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC6 for 3 cycles every 21 days (+/- 3 days) as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W (+/- 3 days) if applicable and depending on surgery results. Patients that will not receive adjuvant treatment will start follow up phase after end of treatment visit. Follow up for all patients must be done for 2 years. The primary objective is to evaluate the complete resection (R0) rate after induction treatment defined as the absence of residual tumor in patients treated with neoadjuvant chemo-immunotherapy.Secondary objectives and endpoint are Overall survival rate at 24 months and disease-free survival rate at 24 months. Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. The study will end once survival follow-up has concluded.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital De Mataro, Mataró, Barcelona, Spain
Hospital Universitario Jerez De La Frontera, Jerez De La Frontera, Cádiz, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital General Universitario de Elche, Alicante, , Spain
Hospital Universitari Quiron Dexeus, Barcelona, , Spain
Hospital Universitari Vall d' Hebron, Barcelona, , Spain
Hospital Clínic De Barcelona, Barcelona, , Spain
Hospital Parc Taulí, Barcelona, , Spain
Hospital Universitario de Cruces, Bilbao, , Spain
Hospital San Pedro De Alcántara, Cáceres, , Spain
Hospital Josep Trueta, Girona, , Spain
Hospital Universitario de Jaén, Jaén, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital 12 De Octubre, Madrid, , Spain
Hospital Universitario la Paz, Madrid, , Spain
Fundació Althaïa, Manresa, , Spain
Hospital Universitario Regional de Málaga, Málaga, , Spain
Hospital Son Espases, Palma De Mallorca, , Spain
Hospital Universitario Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Consorci Sanitari de Terrassa, Terrassa, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valladolid, Valladolid, , Spain
Complexo Hospitalario Universitario De Vigo, Vigo, , Spain
Contact Details
Name: Mariano Provencio, MD
Affiliation: Fundación GECP President
Role: STUDY_CHAIR
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