drugset / Trial / NCT03529084
Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Erlotinib | Small molecule | — | Oral |
| Comparator | Gefitinib | Small molecule | — | Oral |
| Subject | Nazartinib | Small molecule | — | Oral |