101
Participants
Start Date
October 25, 2018
Primary Completion Date
April 30, 2021
Study Completion Date
April 12, 2023
Durvalumab
Durvalumab 1500 mg every 4 weeks x 3 cycles
Tremelimumab
Tremelimumab 75 mg every 4 weeks x 3 cycles
Cisplatin-based neoadjuvant chemotherapy
"Regimen 1: 21-day treatment cycle x 3 cycles.~* Gemcitabine 1,000-1,200 mg/m2 intravenously on days 1 and 8 every 21 days.~* Cisplatin 70 mg/m2 intravenously on day 1 every 21 days. Regimen 2: ddMVAC 14-day treatment cycle x 4 doses.~* Methotrexate 30mg/m2 intravenously on day 1~* Vinblastine 3mg/m2 intravenously on day 2~* Doxorubicin 30mg/m2 intravenously on day 2~* Cisplatin 70mg/m2 intravenously on day 2 Granulocyte colony-stimulating factor (G-CSF) for 7 consecutive days (days 4 through 10).~Regimen 3: 21-day treatment cycle x 3 cycle~* Gemcitabine 1,000 mg/m2 intravenously on day 1 and 8~* Paclitaxel 80 mg/m2 intravenously on day 1 and 8~* Cisplatin 70mg/m2 intravenously on day 1"
ICO Badalona, Badalona
Hospital Clinic, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
ICO L'Hospitalet, L'Hospitalet de Llobregat
Hospital 12 de Octubre, Madrid
Hospital Clinico San Carlos, Madrid
Hospital Ramon y Cajal, Madrid
Hospital Universitario La Paz, Madrid
MD Anderson Cancer Center, Madrid
Hospital Marqués de Valdecilla, Santander
Instituto Valenciano de Oncología, Valencia
Collaborators (1)
AstraZeneca
INDUSTRY
Apices Soluciones S.L.
INDUSTRY
Fundacion CRIS de Investigación para Vencer el Cáncer
OTHER