SPLENDOUR: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy

• Research type

  Research Study

• Full title

  A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC.

• IRAS ID

  157039

• Contact name

  Sarah Danson

• Contact email

  s.danson@shef.ac.uk

• Sponsor organisation

  ETOP (European Thoracic Oncology Platform)

• Eudract number

  2013-003156-21

• Clinicaltrials.gov Identifier

  NCT02129699

• Duration of Study in the UK

  4 years, 8 months, 0 days

• Research summary

  This is a phase III trial evaluating the addition of denosumab to standard anticancer treatment for patients with advanced lung cancer.

  Patients will be randomized in two arms:

  ARM A: 4 – 6 cycles of chemotherapy + best supportive care
  ARM B: 4 – 6 cycles of chemotherapy + denosumab, every 3-4 weeks until unacceptable toxicity, patient refusal or patient’s death. Denosumab will be continued upon tumour progression and concomitantly to subsequent lines of systemic treatment, as long as tolerable for the patient, and for a maximum of 2 years after the required number of 847 deaths for the final analysis has been reached.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  14/YH/1178

• Date of REC Opinion

  13 Oct 2014

• REC opinion

  Favourable Opinion