Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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