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).
The study population will consist of patients with histologically or cytologically proven stage IV NSCLC, who have not been previously treated with chemotherapy for stage IV and are either elderly (70 years of age and older). Patients must fulfill all the inclusion/exclusion criteria to be eligible. Tissue will be obtained, and gene expression analysis will be performed at the University of Turin. The tissue sample used for this analysis will be obtained from the biopsy procedure performed as standard of care procedures during the patient's diagnosis and staging. Patients will be randomized to either Arm A: Experimental or Arm B: Standard of Care in a 2:1 fashion. Tissue will be obtained for gene analysis for ALL patients. However, ONLY patients randomized to Arm A will receive the genetic analysis results. Genetic results will not be disclosed to the registering center for those patients randomized to Arm B: Standard of Care. For patients randomized to Arm A: Experimental arm, the chemotherapy treatment prescription will be based on the gene analysis according to the protocol. For patients randomized to Arm B: Standard of Care arm, the chemotherapy treatment will be at the discretion of the care provider.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
567
IRCSSIstituto Scientifico Romagnolo per lo studio e la cura dei tumori IRST
Meldola, Forlì, Italy
RECRUITINGIstituto Nazionale Tumori
Aviano, Pordenone, Italy
RECRUITINGOspedale di Faenza
Faenza, Ravenna, Italy
RECRUITINGOspedale di Lugo
Lugo, Ravenna, Italy
RECRUITINGAUSL Rimini-Oncologia Medica Cattolica
Cattolica, Rimini, Italy
RECRUITINGAOU San Luigi Gonzaga, Department of Oncology, University of Turin
Orbassano, Turin, Italy
RECRUITINGOspedale Giovanni Paolo II
Bari, Italy
RECRUITINGAO Cannizzaro
Catania, Italy
RECRUITINGAOU Santa Croce e Carle
Cuneo, Italy
RECRUITINGAzienda Ospedaliera Careggi
Florence, Italy
RECRUITING...and 18 more locations
Overall Survival
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.
Time frame: from the date of randomization
Progression Free survival
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%.
Time frame: at six months determined from the date of randomization
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