90
Participants
Start Date
May 15, 2019
Primary Completion Date
November 30, 2027
Study Completion Date
November 30, 2028
Paclitaxel
"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.~The infusions must be mixed as soon as possible before the start of each infusion since the stability of paclitaxel beyond 24 hours is not known.~In-line filtration is obligatory since a small number of fibers within the acceptable limits of the USP Particulate Matter Test for LVP have been reported. Cellulose acetate filters of 0.22-micron pore size (such as IVEX II) can be used. The solution that shows excessive particulate matter must be rejected."
Carboplatin
Carboplatin must be administered at the end of the Paclitaxel infusion
Nivolumab
"Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.~The administration of nivolumab infusion must be completed within 24 hours of preparation."
Hospital Universitario Reina Sofía, Córdoba
Complejo Hospitalario Universitario A Coruña, A Coruña
Hospital Dr. Josep Trueta, Girona
Hospital Clínico San Carlos, Madrid
Hospital Universitario Fundación Jiménez Díaz, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario La Paz, Madrid
Hospital Universitario Puerta de Hierro, Majadahonda
Hospital General Universitario de Málaga, Málaga
Hospital Universitario Insular de Gran canaria, Las Palmas de Gran Canaria
Complejo Hospitalario Universitario de Vigo, Vigo
Hospital Clínico de Salamanca, Salamanca
Hospital Virgen del Rocío, Seville
Hospital Clínico Universitario de Valencia, Valencia
Hospital General de Valencia, Valencia
Hospital Clínico Universitario de Valladolid, Valladolid
Hospital Universitario de Cruces, Barakaldo
Hospital Clínico Lozano Blesa, Zaragoza
ICO Badalona, Badalona
ICO Hospitalet, L'Hospitalet de Llobregat
Hospital General de Alicante, Alicante
Hospital Universitari Dexeus, Barcelona
Hospital Universitari Vall d' Hebron, Barcelona
Hospital Clínic de Barcelona, Barcelona
Hospital de Sant Pau, Barcelona
Fundación GECP
OTHER