Tailor (Tarceva Italian Lung Optimization tRial) Optimization of erlotinib for the treatment of patients with advanced non small cell lung cancer: an Italian randomised trial

INTERVENTION: Trade Name: TARCEVA*30CPR RIV 150MG Pharmaceutical Form: Coated tablet INN or Proposed INN: ERLOTINIB CLORIDRATO CAS Number: 183379‐69‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: TAXOTERE Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Docetaxel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Trade Name: ALIMTA*1FL POLV 500MG Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Pemetrexed Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 500‐ CONDITION: advanced non‐small cell lung cancer NSCLC after failure of standard first line chemoterapy ; MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non‐small cell lung cancer PRIMARY OUTCOME: Main Objective: To compare the efficacy in terms of OS of erlotinib vs docetaxel given as second line therapy in patients with advanced NSCLC Primary end point(s):  PFS is defined as the time from the date of randomisation up to the date of first progression, second primary malignancy or death from any cause, whichever comes first. Subjects who have not progressed or died while on study will be censored at the last disease assessment date.  ; ; OS is defined as the time from the date of randomisation to the date of death from any cause. Subjects who were not reported as having died at the time of the analysis will be censored at the date they were last known to be alive.  ; ; Toxicity, graded according to the NCI‐CTAE version 3.0  ; ; Frequency and nature of serious adverse reactions  ; ; Premature withdrawals Secondary Objective: To compare: ‐ PFS ‐ RR ‐ Quality of life INCLUSION CRITERIA:  Age 18 years or older  Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study.  Absence of EGFR mutations  Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy  One prior chemotherapy regimens, at least one of which must have been platinum‐based and taxanes free. Patients who initially presented with early stage disease but subsequently progressed or recurred are eligible if they received full dose platinum‐based taxanes free adjuvant chemotherapy at full cytotoxic doses of platinum therapy as part of a chemotherapy/radiotherapy regimen. They will not be eligible if they have only received platinum at a radiosensitizing dosage (prior surgery and/or localized irradiation are allowed)  Measurable (uni‐dimensional) disease by Response Evaluation C