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, was 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.

Trial Scheme


Trial Information

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
First Patient In:
14 January 2013
Accrual Closure Date:
31 January 2014
Global Trial Completion Date:
19 November 2015

Trial Organisation

Trial Chairs:
Egbert Smit and Solange Peters
Coordinating Group:
Participating Groups:
Central European Cooperative Oncology Group (CECOG), Hellenic Oncology Research Group (HORG), All-Ireland Cooperative Oncology Research Group (ICORG), Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT), Swiss Group for Clinical Cancer Research (SAKK) and Spanish Lung Cancer Group (SLCG)
Participating Countries:
Austria, Belgium, Denmark, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom
EudraCT number: 2012-001896-35
ClinicalTrials.gov:  NCT01652469 


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