first-line chemotherapy in elderly patients with locally advanced (stage IIIb) or metastatic (stage IV) Non Small Cell Lung Cancer (NSCLC). MedDRA version: 9.1 Level: LLT Classification code 10025065 Term: Lung carcinoma cell type unspecified recurrent
Conditions
Interventions
Trade Name: ALIMTA*1FL POLV 500MG
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: NSCLC, locally advanced (stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy Female or male patients aged 70 years and over Measurable disease according to RECIST criteria, with at least one measurable lesion No prior chemotherapy, biological or immunological therapy Adeguate hepatic, renal and bone marrow function ECOG Performance Status ≤ 2 Life expectancy of at least 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Newly diagnosed CNS metastases that have not been treated with surgery or radiation Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity Any other experimental or anti-cancer therapy within 30 days before study drug administration Concurrent treatment with any other experimental or anti-cancer therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients.;Secondary Objective: Overall Survival Quality of life;Primary end point(s): Progression Free Survival | — |
Countries
Italy
Outcome results
None listed