Study
EORTC-08111
A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC
Trial Status
All trial activities ended
Dates
Date of activation: 11-Dec-2014
Date Step1 close: 31-Jan-2018
Date Step2 close: 31-Jan-2018
Date Step1 close: 31-Jan-2018
Date Step2 close: 31-Jan-2018
Data management at EORTC
Yes
Design
Phase 3
Randomized open label
Randomized open label
Targeted Sample size
EORTC Groups: 500 - All Groups: 1000
Protocol summary
NCT number
NCT02129699
EudraCT
Study
EORTC-08111-ETOP5-12 (SPLENDOUR)
A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC
Research Projects
RP-2560-TRIAL-GEN
Reforming Clinical TRIAL Eligibility for Improved GENeralisability – A Multifaceted-Study on EORTC Protocols, Investigator's Survey, Screening Data, and Real-world Evidence