advanced and/or metastatic NSCLC MedDRA version: 9.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic
Conditions
Interventions
Trade Name: ALIMTA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 histologic or cytologic confirmation of NSCLC measurable disease PS = ECOG 0-2 WBC ≥3500 e PLT ≥ 100.000 adequate bone marrow, renal, and hepatic function. written informed consent before treatment 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: prior chemotherapy with pemetrexed autoimmune disease interfering with radiotherapy pregnancy other concomitant neoplasm mentally disturbed patients with low compliance to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical response evaluation;Secondary Objective: Acute toxicity evaluation, DFS and OS evaluation, Identify the most effective low-dose per fraction;Primary end point(s): Clinical response Identify the most effective low-dose per fraction and evaluate its efficacy, combined with a pemetrexed-based regimen, in patients affected by locally advanced and/or metastatic NSCLC, previously treated with chemotherapy | — |
Countries
Italy
Outcome results
None listed