CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,017 enrolled
Drug / intervention
AZD9291 Dosing +4 moredrug
Likely dose
Not stated in 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/NCT02474355
NCT02474355Phase 3Completed
CompareCT.gov

Open Label, Multinational, Multicenter, Real World Treatment Study of Single Agent AZD9291 for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Prior Therapy With an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI)

AstraZeneca·interventional·Posted Jun 17, 2015·Updated Nov 11, 2021

In Brief

A Phase 3 clinical trial evaluating T790M+ Testing, Baseline Visit Blood & Urine Testing, and 3 other interventions for Lung Cancer. Completed, enrolled 3,017 participants across 201 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Ireland, Italy, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, United Kingdom
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 17, 2015
Enrollment StartSep 18, 2015
Primary CompletionApr 18, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.0 years ago

Interventions

T790M+ Testingprocedure

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

Baseline Visit Blood & Urine Testingprocedure

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

Baseline ECGprocedure

ECG to ensure absence of any cardiac abnormality

Visual Slit-Lamp Testingprocedure

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

AZD9291 Dosingdrug

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