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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
| 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 |
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| 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
ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
