Rationale for treatment and study design of tailor: a randomized phase III trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor receptor mutations.

摘要: We present the rationale and study design of Tarceva Italian Lung Optimization trial phase III, multicenter, open-label, randomized on efficacy second-line therapies in different subgroups non-small-cell lung cancer (NSCLC) patients identified using molecular clinical evaluations. To date, we can assume that advanced NSCLC epidermal growth factor receptor (EGFR)-mutated benefit from EGFR tyrosine kinase inhibitors, such as gefitinib erlotinib, whereas their role treatment who do not have mutations is controversial. The aim this to assess whether it possible optimize with absence mutations. Moreover, predictive value K-ras mutation, protein expression, gene copy number, well a smoking habit histotype for determining effect erlotinib compared chemotherapy will be assessed primary endpoint overall survival; secondary endpoints are progression-free survival, response rate, quality life, toxicity. planned collect blood samples identify prognosis-related polymorphisms sensitivity specificity detection respect histologic samples.