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RECRUITING
NCT05684276
PHASE2

DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors

Sponsor: Fundación GECP

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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