MedTrace Logo

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

NCT02972333 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-11-23

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Jinming Yu, MD.PhD. · Shandong Cancer Hospital and Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-09-30
Completion
2019-12-31

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02972333 on ClinicalTrials.gov