RecruitingPhase 2NCT05684276

DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors

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


Sponsor

Fundación GECP

Enrollment

22 participants

Start Date

May 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (DUMAS) is testing whether immunotherapy given before surgery can shrink a rare type of lung cancer called a Pancoast tumor — a tumor at the very top of the lung that often involves nearby nerves or blood vessels. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with a Pancoast tumor (a non-small cell lung cancer at the top of the lung), confirmed by biopsy - Your cancer has not spread to distant parts of the body - You have not yet received any treatment for this cancer - You are in good enough physical health to undergo surgery (ECOG 0–2) - Your lung function meets minimum requirements **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have already received treatment for this lung cancer - You have significant autoimmune disease or are taking immune-suppressing medications - Your lung function is too low for surgery - You have a history of severe immune-related reactions to prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

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.

DRUGPaclitaxel

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.

DRUGNivolumab

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

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NCT05684276


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