43
Participants
Start Date
October 30, 2018
Primary Completion Date
September 30, 2020
Study Completion Date
May 27, 2021
Avelumab
Participants received avelumab intravenous infusions at a dose of 800 milligram (mg) on Day 1 and Day 8 of each 3-week cycle for the first 4 cycles. Thereafter, administered every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.
Cetuximab
Participants received cetuximab intravenous infusions at a dose of 250 milligram per meter square (mg/m\^2) body surface area on Day 1 and 500 mg/m\^2 body surface area on Day 8 of first 4 cycles of concurrent chemotherapy. Thereafter, administered given at a dose of 500 mg/m\^2 intravenous every 2 weeks in the Maintenance phase, until disease progression or unacceptable toxicities.
Gemcitabine
Participants received gemcitabine intravenous infusions at a dose of 1250 mg/m\^2 body surface area on Day 1 and Day 8 in 3-week cycles up to a maximum of 4 cycles, until disease progression or unacceptable toxicities.
Cisplatin
Participants received cisplatin intravenous infusions at a dose of 75 mg/m\^2 body surface area on Day 1 of 3-week cycles up to a maximum of 4 cycles, until disease progression or unacceptable toxicities.
Carboplatin
In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles.
Semmelweis Egyetem - Pulmonologiai Klinika, Budapest
Tudogyogyintezet Torokbalint - Onkopulmonologiai es Jarobeteg centrum, Törökbálint
Debreceni Egyetem - Tudogyogyaszati Klinika, Debrecen
Zala Megyei Szent Rafael Korhaz, Zalaegerszeg
Petz Aladar Megyei Oktato Korhaz - Pulmonologiai Osztaly, Győr
Markusovszky Egyetemi Oktatokorhaz, Szombathely
Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia, A Coruña
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica, Madrid
Hospital Universitario 12 de Octubre - Servicio de Oncologia, Madrid
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia, Madrid
Hospital Regional Universitario de Malaga, Málaga
Hospital Universitario Virgen Macarena - Servicio de Oncologia, Seville
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica, Valencia
Hospital Clinico Universitario Lozano Blesa - Dept of Oncology, Zaragoza
"Clinical Center Bezanijska kosa - Department of Oncology", Belgrade
Clinical Center Kragujevac (no dept.), Belgrade
Institute for Pulmonary Diseases of Vojvodina, Kamenitz
Hospital Universitario Virgen del Rocio, Seville
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica, Barcelona
Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona
Merck KGaA, Darmstadt, Germany
INDUSTRY