38
Participants
Start Date
June 16, 2021
Primary Completion Date
November 15, 2026
Study Completion Date
November 15, 2027
Carboplatin
"Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine 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 each center.~Other Name: ATC code: L01XA02"
Placlitaxel
"Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-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 than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.~Guidelines of 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."
Atezolizumab
"Atezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that is produced in Chinese hamster ovary (CHO) cells. Atezolizumab targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells.~Patients will receive 1200 mg of atezolizumab administered by IV infusion every 21 days (+/- 3 days) in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions."
Hospitalario Universitario A Coruña, A Coruña
ICO Girona, Hospital Josep Trueta, Girona
Hospital Universitario de Jaén, Jaén
Hospital Universitario Lucus Augusti, Lugo
Hospital Universitario Infanta Leonor, Madrid
Hospital Clínico San Carlos, Madrid
Hospital Universitario Fundación Jiménez Díaz, Madrid
Hospital Universitario HM Sanchinarro, Madrid
Hospital Universitario Puerta de Hierro, Majadahonda
Hospital Universitario Severo Ochoa, Leganés
Hospital Santa María Nai, Ourense
Hospital Universitario Insular de Gran canaria, Las Palmas de Gran Canaria
Hospital Clínico de Valencia, Valencia
Hospital General Universitario de Valencia, Valencia
Hospital Clínico Universitario de Valladolid, Valladolid
Hospital de Basurto, Bilbao
Hospital General Universitario de Elche, Elche
ICO Badalona, Hospital Germans Trias i Pujol, Badalona
Hospital General Universitario de Alicante, Alicante
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Parc Taulí, Barcelona
Hospital Son Espases, Palma de Mallorca
Fundación GECP
OTHER