AZD9291 for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
Research Site, Atlanta, GANon-Small Cell Lung Cancer+1 MoreAZD9291 - Drug
18 - 130
All Sexes
What conditions do you have?

Study Summary

This trial will test a new drug on patients with NSCLC who have already tried other treatments. They will look at side effects, how much of the drug is in the body, and how well it works against the cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)

Month 12
Best Objective Response (BOR) for 80mg AZD9291 Extension Population
Objective Response Rate (ORR) for Extension Population
Month 21
Duration of Response (DoR) for Dose Expansion Population
Objective Response Rate (ORR) for Dose Expansion Population
Progression-Free Survival (PFS) for Dose Expansion Population
Month 25
Best Objective Response (BOR) for Dose Escalation Population

Trial Safety

Safety Progress

1 of 3

Side Effects for

Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736
50%Atrial fibrillation
50%Enterocolitis infectious
50%Mitral valve stenosis
50%Oedema peripheral
50%Thrombosis in device
50%Deep vein thrombosis
50%Hot flush
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02179671) in the Selumetinib+Docetaxel With a Seq. Switch to a MEDI4736 ARM group. Side effects include: Constipation with 100%, Diarrhoea with 100%, Dyspepsia with 100%, Vomiting with 100%, Myalgia with 100%.

Trial Design

1 Treatment Group

Daily dose of AZD9291
1 of 1

Experimental Treatment

603 Total Participants · 1 Treatment Group

Primary Treatment: AZD9291 · No Placebo Group · Phase 1 & 2

Daily dose of AZD9291
Experimental Group · 1 Intervention: AZD9291 · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: recist tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,021 Previous Clinical Trials
240,380,522 Total Patients Enrolled
Yuri RukazenkovStudy DirectorAstraZeneca
3 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

What is the maximum age limit for participants of this research?

"The trial organisers are searching for individuals of 18 years or older, but under 130 years in age." - Anonymous Online Contributor

Unverified Answer

What is the aggregate amount of participants in this clinical trial?

"At this juncture, this trial does not require any additional enrolment. The first post was made on March 4th 2013 and the last update occurred November 10th 2022. If you are in search of other studies related to lung cancer, 1908 clinical trials have open slots while 101 medical centres offer AZD9291 treatment opportunities." - Anonymous Online Contributor

Unverified Answer

What other trials have been conducted utilizing AZD9291 as a therapeutic agent?

"Currently, 101 AZD9291 studies are in progress. 17 of them have reached Phase 3 status while the rest remain at earlier stages. 4699 medical facilities across the United States, with a main hub based in Uniondale New York, are recruiting patients for these trials." - Anonymous Online Contributor

Unverified Answer

How many locales have been chosen for this scientific investigation?

"The present iteration of this clinical trial is recruiting participants from 6 medical centres, including those in Houston, Atlanta and Boston to name a few. To reduce the burden associated with travel for potential volunteers, it is advised to consider sites closest geographically." - Anonymous Online Contributor

Unverified Answer

Is this a pioneering clinical trial?

"Presently, 101 clinical trials for AZD9291 are taking place in 1059 cities and 51 nations. AstraZeneca sponsored the initial test of this medication back in 2013; 603 patients participated across Phase 1 & 2 drug approval stages. Since then, 30 studies have concluded successfully." - Anonymous Online Contributor

Unverified Answer

What criteria must potential participants meet to be eligible for this clinical investigation?

"This clinical trial is seeking 603 individuals aged between 18 and 130 suffering from lung cancer. Participants must also fulfil the following criteria: evidence of disease progression whilst on continuous EGFR TKI treatment; confirmation that tumours harbour an EGFR mutation linked to sensitivity towards such drugs (e.g G719X, exon 19 deletion, L858R or L861Q); documented clinically benefit from a previous round of ERFGR therapy per Jackman et al 2010 followed by systemic objective regression as specified in RECIST/WHO guidelines; women should be using contraceptive devices and have taken a negative pregnancy test prior to dosing comm" - Anonymous Online Contributor

Unverified Answer

Does this investigation currently require participants?

"As documented on, the recruitment for this medical trial has been concluded. It was initially posted in March 2013 and its information was last modified in November 2022; nevertheless, there are 2,009 other studies that have opened their enrollment process at present." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.