This is a randomized phase III trial that will randomize elderly patients(70 years of age and older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1 fashion, patients will be randomized to the customization arm or the standard arm, respectively. This trial will be offered to patients who are previously untreated for stage IV NSCLC. The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1, RRM1 and TS (arm A, the experimental arm) results in superior outcome in elderly patients with untreated, advanced NSCLC compared to standard of care treatments (arm B, the standard arm).
Description: primary endpoint is OS (determined from the date of randomization).Assuming an exponential survival distribution for both treatment arms and a median survival time of 8 months in the control arm we anticipate to detect an improvement of three months in OS.Measure: Overall Survival Time: from the date of randomization
Description: PFS at 6 months (determined from the date of randomization). The anticipated 6-month PFS in arm B is approximately 25% and the goal in the experimental arm is to achieve a 32% improvement to 33%.Measure: Progression Free survival Time: at six months determined from the date of randomization
Description: adverse events and serious adverse events as a measure of safety and tolerabilityMeasure: AE and SAE (according to CTCAE version 4.0) Time: every week from the day 1 treatment until the end of treatment (up to 18 weeks)
Description: Rate of successfully conducted gene expression analysis in patients that have signed the informed consent documentMeasure: Rate of successfully conducted gene expression analysis in patients that have signed the informed consent document Time: up to10 business days of submission of the tumor specimen
There is one SNP
T790M and D770. --- T790M ---