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

Data management at EORTC

Yes

Design

Phase 3
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