Link to EORTC-8111-LCG
A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC
SPLENDOUR: Survival imProvement in Lung cancEr Induced by DenOsUmab theRapy
Denosumab is a monoclonal antibody targeting and inhibiting RANKL, a protein that acts as the primary signal for bone resorption. The trial was designed to investigate the potential of denosumab added to standard treatment (chemotherapy) compared to standard treatment alone to increase survival of patients with advanced NSCLC with or without bone metastasis in advanced unselected treatment-naïve patients.
After the excellent initial recruitment, the accrual rate has dramatically slowed down, potentially due to more attractive treatment alternatives for this patient population, in the context of a competitive landscape of ongoing immune-oncology clinical trials. The trial Steering Committee has therefore decided to close the recruitment prematurely. No safety concerns led to this decision. Treatment and follow-up of all included patients continues as specified in the protocol. A manuscript with the final analysis is currently in preparation.
Trial Scheme
| Primary Endpoint: | Overall survival |
| Secondary Endpoints: |
Progression free survival Objective response Toxicities of treatment Evaluation of potential predictive biomarkers for denosumab activity |
| Target Sample Size: | 1000 Patients |
| Final Accrual: | 514 Patients |
| Protocol Release Date: | 27 May 2014 |
| Trial Activation Date: | 18 August 2014 |
| First Patient In: | 12 January 2015 |
| Accrual Closure Date: | 10 January 2018 |
| Global Trial End Date: | 10 September 2018 |
Trial Organisation |
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| ETOP Trial Chair: |
Solange Peters |
| Sponsor: |
ETOP |
| Coordinating Group: | EORTC |
| Participating Countries: |
Austria, Belgium, France, Germany, Ireland, Italy, Slovenia, Spain Switzerland and United Kingdom |
| Registrations: |
EudraCT number: 2013-003156-21 ClinicalTrials.gov: NCT02129699 |
Contact
Virginia Rodriguez Martinez (Trial Manager)
Tel: +41 31 511 94 48
This email address is being protected from spambots. You need JavaScript enabled to view it.
European Thoracic Oncology Platform
c/o IBCSG
Effingerstrasse 40
3008 Bern, Switzerland
Tel: +41 31 511 94 00
