NCT03402048

The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 567 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Stage IV, NSCLC
• Lung Neoplasms
• Bronchial Neoplasms
• Carcinoma, Bronchogenic
• Lung Diseases
• Neoplasms
• Respiratory Tract Diseases
• Respiratory Tract Neoplasms
• Thoracic Neoplasms

Interventions

Type	Name	Description
DRUG	Carboplatin
DRUG	Gemcitabine
DRUG	Pemetrexed
DRUG	Docetaxel
DRUG	Vinorelbine

Timeline

• Start date: 2012-07-01
• Primary completion: 2020-12-01
• Completion: 2021-05-01
• First posted: 2018-01-17
• Last updated: 2020-11-04

Locations

28 sites across 1 country: Italy