non small cell lung cancer MedDRA version: 6.1 Level: PT Classification code 10062042
Conditions
Interventions
Trade Name: TARCEVA
Pharmaceutical Form: Tablet
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 150-
Trade Name: ALIMTA
Pharmaceutical Form: Powder for infu
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: š Histologically confirmed diagnosis of NSCLC š Advanced NSCLC (stage IIIB or IV) patients previously treated with non TKIs as a first-line therapy š Age ³18 years š ECOG Performance status 0 to 2 š Presence of measurable disease š Absolute granulocyte count (AGC) >1.5 x 109/l š Platelets ≥ 100 x 109/l š Bilirubin 50 ml/min š Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to enrollment Informed written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient who can not comply with planned protocols procedures š Patient with multiple severe diseases who can compromise safety (cardiac and renal failure, peripheral neuropathy) š Clinical evidence of uncontrolled brain metastases š Other malignancy (except basal skin carcinoma) or pre-neoplastic condition not requiring chemotherapeutic treatment š Pregnancy or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The aim of this multi-center prospective randomized study is to evaluate the efficacy of erlotinib versus standard chemotherapy (CT) as second-line treatment in proteomic-based selected population of patients with advanced NSCLC.;Primary end point(s): PFS, defined as the time elapsed from the date of randomisation and the date of progression after second-line treatment or death, whichever come first. Patients who will be alive and not progressed at the end of the study will be censored on the date of the last assessment.;Main Objective: The aim of this multi-centrer prospective randomized study is to evaluate the efficacy of erlotinib versus standard chemotherapy (CT) as second-line treatment in proteomic-based selected population of patients with advanced NSCLC. | — |
Countries
Italy
Outcome results
None listed