A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor

EMPHASIS-lung: Erlotinib MALDI TOF PHAse III SIgnature in Squamous cell non-small cell lung cancer

In the EMPHASIS-lung trial, the potential of Veristrat, a clinically validated serum proteomic test, to predict response to treatment by erlotinib or docetaxel, is being assessed in pre-treated patients with advanced squamous cell lung carcinoma.

Recruitment was terminated prematurely due to an accrual rate that was deemed insufficient and publication of controversial new data from another study. No safety concerns led to the decision to close accrual. Treatment and follow-up continued as specified in the protocol.

Trial Scheme

Scheme

 

 

Primary Endpoint: Progression free survival
Secondary Endpoints:

Overall survival

Toxicities of treatment

Objective response rate

Disease control rate

Target Sample Size: 500 Patients 
Final Accrual: 81 Patients
   
Protocol Release Date: June 2012
Trial Activation Date: August 2012
Accrual Closure Date: 31 January 2014
Last Patient Last Visit: 19 November 2015

Trial Organisation

Trial Chairs: Egbert Smit and Solange Peters
Sponsor: ETOP
Coordinating Group: ETOP
Participating Groups: CECOG, HORG, ICORG, NVALT, SAKK and SLCG   
Participating Countries:
Austria, Belgium, Denmark, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Spain, Switzerland  and United Kingdom
Registrations:

EudraCT number: 2011-004481-15

ClinicalTrials.gov: NCT01652469 

 

Contact

Susanne Roux (Head Trial Management)

Tel: +41 31 511 94 17

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