226
Participants
Start Date
December 31, 2013
Primary Completion Date
July 29, 2016
Study Completion Date
November 28, 2017
Denosumab
Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.
Zoledronic acid
Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.
Placebo to Denosumab
Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.
Standard Chemotherapy
Standard of care chemotherapy consisting of pemetrexed or gemcitabine in combination with cisplatin or carboplatin administered according to local practice.
Placebo to Zoledronic Acid
Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.
Research Site, Wahroonga
Research Site, Kogarah
Research Site, Footscray
Research Site, Parkville
Research Site, Wodonga
Research Site, Adelaide
Research Site, Orbassano (TO)
Research Site, Athens
Research Site, East Setauket
Research Site, Athens
Research Site, Caen
Research Site, Berlin
Research Site, Monza (MB)
Research Site, Saronno VA
Research Site, Dijon
Research Site, Westminster
Research Site, Großhansdorf
Research Site, Pátrai
Research Site, Pavia
Research Site, Winston-Salem
Research Site, Durham
Research Site, Hickory
Research Site, Pessac
Research Site, Tours
Research Site, Nashville
Research Site, Nantes
Research Site, Cincinnati
Research Site, Detroit
Research Site, Reims
Research Site, Köln-Merheim
Research Site, Thessaloniki
Research Site, Thessaloniki
Research Site, Bismarck
Research Site, Heraklion
Research Site, Alexandria
Research Site, Paris
Research Site, Paris
Research Site, Paris
Research Site, Goodyear
Research Site, Ulm
Research Site, Los Angeles
Research Site, Los Angeles
Research Site, Long Beach
Research Site, Anaheim
Research Site, Farmington
Research Site, Brewer
Research Site, Fairhaven
Research Site, Edmonton
Research Site, Saint John
Research Site, Greater Sudbury
Research Site, Kitchener
Research Site, Toronto
Research Site, Toronto
Research Site, Montreal
Research Site, Chomutov
Research Site, Ostrava-Poruba
Research Site, Pardubice
Research Site, Prague
Research Site, Ústí nad Labem
Research Site, Saint-Quentin
Research Site, Roma
Research Site, 's-Hertogenbosch
Research Site, Arnhem
Research Site, Harderwijk
Research Site, Tilburg
Research Site, Zutphen
Research Site, Bristol
Research Site, Exeter
Research Site, Glasgow
Research Site, Guildford
Research Site, London
Research Site, London
Research Site, Plymouth
Research Site, Preston
Lead Sponsor
Amgen
INDUSTRY