NCT02250846

Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

Phase II Study of EGFR-TKI in Patients With EGFR Mutation Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.

Detailed description

A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.

Conditions

• Asymptomatic Brain Metastases of Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	EGFR-TKI	egfr-TKI treatment

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2014-09-26
• Last updated: 2014-09-26