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DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors
Sponsor: Fundación GECP
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2023-05-12
Completion Date
2028-06-01
Last Updated
2025-04-10
Healthy Volunteers
No
Conditions
Interventions
Carboplatin
Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, sodium chloride and glucose 5% solution solution or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of ech center.
Paclitaxel
Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hydroxy-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine. Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Nivolumab
Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains. Route of administration: Intravenous infusion. Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml. Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing. Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 3 cycles. For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles). Subjects should be carefully monitored during nivolumab administration to follow infusion reactions. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.
Locations (29)
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
Seville, 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