Tarceva Italian Lung Optimization tRial

  • STATUS
    Recruiting
  • participants needed
    850
  • sponsor
    Fatebenefratelli and Ophthalmic Hospital
Updated on 7 November 2020
erlotinib
EGFR
docetaxel
tarceva

Summary

The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.

Description

Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients. Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome. For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.

Details
Condition Non-Small Cell Lung Cancer
Treatment docetaxel, Erlotinib
Clinical Study IdentifierNCT00637910
SponsorFatebenefratelli and Ophthalmic Hospital
Last Modified on7 November 2020

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