drugset / Trial / NCT03529084

Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations

NCT03529084

Phase 3 Withdrawn Novartis Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a phase III, open label, randomized controlled multi-center global study designed to evaluate the safety and efficacy of single agent nazartinib (EGF816) compared with investigator's choice (erlotinib or gefitinib) in patients with locally advanced or metastatic NSCLC who are treatment naïve and whose tumors harbor EGFR activating mutations (L858R or ex19del).

Timeline

Start
2018-07-24
Primary completion
2020-08-13
Completion
2024-06-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Erlotinib Small molecule Oral
Comparator Gefitinib Small molecule Oral
Subject Nazartinib Small molecule Oral