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

SPLENDOUR trial design

 

 

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
Accrual Closure Date: 10 January 2018
Last Patient Last Visit: -

Trial Organisation

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:

Florence Berger (Trial Manager)

Tel: +41 31 511 94 48

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European Thoracic Oncology Platform
c/o IBCSG
Effingerstrasse 40
3008 Bern, Switzerland
Tel: +41 31 511 94 00