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Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC

NCT02474355 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3017

Last updated 2021-11-11

Study results available
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Summary

The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy.

Conditions

Interventions

PROCEDURE

T790M+ Testing

If a previous lab report is unavailable, the patient will need to have T790M+ testing.

PROCEDURE

Baseline Visit Blood & Urine Testing

Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria

PROCEDURE

Baseline ECG

ECG to ensure absence of any cardiac abnormality

PROCEDURE

Visual Slit-Lamp Testing

Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms

DRUG

AZD9291 Dosing

Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-18
Primary Completion
2019-04-18
Completion
2019-04-18

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • Ireland
  • Italy
  • Saudi Arabia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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 NCT02474355 on ClinicalTrials.gov