CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 150 target
Drug / intervention
AZD9291 80mg oral each day +1 moredrug
Likely dose
AZD9291 80mg oral each dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02972333
NCT02972333Phase 3Unknown
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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

Shandong Cancer Hospital and Institute·interventional·Posted Nov 23, 2016·Updated Nov 23, 2016

In Brief

A Phase 3 clinical trial evaluating AZD9291 80mg oral each day and Radiation therapy for EGFR-TKI Resistant Mutation and 3 related conditions. Targeting 150 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEGFR-TKI Resistant Mutation, Nonsmall Cell Lung Cancer, AZD9291, Brain Metastases
Countries--
CollaboratorsAstraZeneca

Timeline

Phase 3UnknownOverdue
2017201820192020202120222023202420252026
First PostedNov 23, 2016
Enrollment StartDec 1, 2016
Primary CompletionSep 1, 2019
Study CompletionDec 1, 2019
TodayJul 1, 2026
Enrollment to primary: 2.8 yearsPosted 9.6 years ago

Interventions

AZD9291 80mg oral each daydrug

All eligible patients will have access to AZD9291 regimen through the ASTRIS study as long as they continue to show clinical benefit.

Radiation therapyradiation

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.