NCT02972333

Open Label, Prospective Study to Investigate Efficacy and Safety of AZD9291 in BM From NSCLC Patients With EGFR T790M

Open Label, Multi-center, Prospective Study to Investigate the Efficacy and Safety of AZD9291 in Brain Metastases From Patients With EGFR T790M Positive NSCLC Who Have Received Prior Therapy With an EGFR-TKI

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to investigate the efficacy and safety of AZD9291 in brain metastases from patients with EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI.

Detailed description

Patients with confirmed EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI and concurrent with brain metastasis will be enrolled into the study. All eligible patients will have access to AZD9291 regimen through the ASTRIS study as long as they continue to show clinical benefit.

Conditions

• EGFR-TKI Resistant Mutation
• Nonsmall Cell Lung Cancer
• AZD9291
• Brain Metastases

Interventions

Type	Name	Description
DRUG	AZD9291 80mg oral each day	All eligible patients will have access to AZD9291 regimen through the ASTRIS study as long as they continue to show clinical benefit.
RADIATION	Radiation therapy	Radiation therapy will be implemented according to investigator's clinical practice.Based on the guidelines provided for the interruption of ADZ9291 with brain radiation therapy, a 7-10 days washout period before radiotherapy and 1 week period after completion of brain radiothearpy before re-starting AZD9291.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2016-11-23
• Last updated: 2016-11-23