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The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

NCT03402048 ↗

Phase 3 Unknown 567 enrolled University of Turin, Italy
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2012-07
Primary completion
2020-12
Completion
2021-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications

bronchogenic carcinoma non-small cell lung carcinoma