DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors

PHASE2RecruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 12, 2023

Primary Completion Date

March 1, 2028

Study Completion Date

June 1, 2028

Conditions
NSCLCPancoast Tumor
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."

Trial Locations (29)

10003

RECRUITING

Hospital San Pedro De Alcántara, Cáceres

11407

RECRUITING

Hospital Universitario Jerez De La Frontera, Jerez de la Frontera

17007

RECRUITING

Hospital Josep Trueta, Girona

23007

RECRUITING

Hospital Universitario de Jaén, Jaén

27003

RECRUITING

Hospital Universitario Lucus Augusti, Lugo

28040

RECRUITING

Hospital Clínico San Carlos, Madrid

RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

RECRUITING

Hospital 12 De Octubre, Madrid

28046

RECRUITING

Hospital Universitario la Paz, Madrid

28222

RECRUITING

Hospital Universitario Puerta de Hierro, Majadahonda

29010

RECRUITING

Hospital Universitario Regional de Málaga, Málaga

36204

RECRUITING

Complexo Hospitalario Universitario De Vigo, Vigo

37007

RECRUITING

Hospital Universitario Salamanca, Salamanca

41013

RECRUITING

Hospital Universitario Virgen Del Rocio, Seville

46010

RECRUITING

Hospital Clínico de Valencia, Valencia

46014

RECRUITING

Hospital General Universitario de Valencia, Valencia

46017

RECRUITING

Hospital Universitario Dr. Peset, Valencia

46026

RECRUITING

Hospital Universitario La Fe, Valencia

47003

RECRUITING

Hospital Clínico Universitario de Valladolid, Valladolid

48903

RECRUITING

Hospital Universitario de Cruces, Bilbao

08304

RECRUITING

Hospital De Mataro, Mataró

03203

RECRUITING

Hospital General Universitario de Elche, Alicante

08028

RECRUITING

Hospital Universitari Quiron Dexeus, Barcelona

08035

RECRUITING

Hospital Universitari Vall d' Hebron, Barcelona

08036

RECRUITING

Hospital Clínic De Barcelona, Barcelona

08208

RECRUITING

Hospital Parc Taulí, Barcelona

08243

RECRUITING

Fundació Althaïa, Manresa

07120

RECRUITING

Hospital Son Espases, Palma de Mallorca

08227

RECRUITING

Consorci Sanitari de Terrassa, Terrassa

All Listed Sponsors
lead

Fundación GECP

OTHER