A randomized phase II study of progression free survival comparing gemcitabine (1250 mg/m2 infusion) versus carboplatin (AUC5 infusion) plus alimta (500 mg/m2 infusion) as first-line chemotherapy in elderly patients with locally advanced (stage IIIb) or metastatic (stage IV) non small cell lung cancer (NSCLC) - ND

• Conditions: first-line chemotherapy in elderly patients with locally advanced (stage IIIb) or metastatic (stage IV) Non Small Cell Lung Cancer (NSCLC).; MedDRA version: 9.1Level: LLTClassification code 10025065Term: Lung carcinoma cell type unspecified recurrent

• Registration Number: EUCTR2008-002126-12-IT
• Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified