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Clinical Trial Summary

Primary objective: · Progression free survival. Secondary objectives: - Assess Overall survival of both treatment groups. - Assess Tumor response rate using RECIST criteria - Assess Toxicity profile of patients enrolled in the study. - Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.


Clinical Trial Description

Study population: Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria). Duration of treatment: Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator. Calendar and planned finalization date: The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00617656
Study type Interventional
Source Spanish Lung Cancer Group
Contact
Status Terminated
Phase Phase 3
Start date February 2008
Completion date April 2015

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