CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 603 enrolled
Drug / intervention
AZD9291drug
Likely dose
AZD9291 20 mgfrom 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/NCT01802632
NCT01802632Phase 2Completed

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

AstraZeneca·interventional·Posted Mar 1, 2013·Updated Apr 20, 2026

In Brief

A Phase 2 clinical trial evaluating AZD9291 for Advanced Non Small Cell Lung Cancer and Advanced (Inoperable) Non Small Cell Lung Cancer. Completed, enrolled 603 participants across 45 sites in 10 countries.

Detailed Summary

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2013
Enrollment StartMar 4, 2013
Primary CompletionMay 1, 2015
Study CompletionDec 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.3 years ago

Interventions

AZD9291drug

Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined