drugset / Trial / NCT02714010
EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.
Timeline
- Start
- 2015-08
- Primary completion
- 2021-12
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Gefitinib | Small molecule | 250 mg | Oral |
| Subject | Icotinib | Small molecule | 125 mg | Oral |