The ASTRIS Study
Research type
Research Study
Full title
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) - The ASTRIS Study
IRAS ID
183031
Contact name
Jessica Bainbridge
Contact email
Sponsor organisation
Astra Zeneca
Eudract number
2015-001407-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 29 days
Research summary
Research Summary
This study is investigating Non Small Cell Lung Cancer (NSCLC), which has a specific change in the gene that produces a protein on the surface of the tumour cell called the Epidermal Growth Factor Receptor (EGFR). This protein is responsible for active tumour growth. When the gene changes it is said to have developed a mutation. This mutation predicts tumour sensitivity to specific drugs called “EGFR tyrosine kinase inhibitors (EGFR TKI)”. Participants with this type of NSCLC have a mutation in EGFR, and been treated with EGFR TKI. Unfortunately, after a period of therapy with EGFR-TKI, some tumours might start growing again because they develop resistance to this treatment due to a second EGFR mutation called T790M (an extra resistance mutation). AZD9291 is predicted to be effective against some tumours that have begun to grow despite EGFR TKI therapy due to the emergence of a T790M mutation.
This Treatment Access Study is being carried out to make AZD9291 available to participants with NSCLC who no longer respond to EGFR-TKI due to the appearance of the second EGFR resistance mutation, T790M, and who do not have currently available optimal treatments for NSCLC.
Every participant who takes part in this Treatment Access Study will receive AZD9291. When AZD9291 becomes commercially available and at the time point of national reimbursement, the Treatment Access Study will end, but if participants are still on-treatment, they will receive the commercially available form of AZD9291. If participants disease gets worse, they will stop the treatment.
If AZD9291 does not become commercially available, the Treatment Access Study may continue for participants who are showing benefit from AZD9291.Summary of Results
All of the participants helped researchers learn more about osimertinib to help people with a type of lung cancer called advanced non-small cell lung cancer, also called “advanced NSCLC”.
Researchers already did studies that showed that osimertinib worked for people with advanced NSCLC. In this study the researchers wanted to find out more about the safety of osimertinib and how well it worked after it had been approved in some countries to be used as a treatment.
All of the participants in this study took osimertinib.
The researchers asked for the help of men and women with advanced NSCLC. The participants in this study were 27 to 92 years old when they joined.
All of the participants had a specific change in a gene called “EGFR T790M positive” in their tumours. This is also called a “mutation”. All of the participants had also previously tried a type of treatment called an “EGFR tyrosine kinase inhibitor”, but their cancer had gotten worse.
The study included 3,017 participants in Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Ireland, Italy, the Republic of Korea, Saudi Arabia, Spain, Sweden, Taiwan, and the United Kingdom.
The study drug, osimertinib, was designed to stop different proteins in the body from allowing the tumours to grow. Osimertinib is already available as a treatment for people with certain types of NSCLC.
Researchers already did studies that showed osimertinib worked for the people with certain types of NSCLC who were in those studies. In this study, the researchers wanted to find out more about the safety of osimertinib and how well it worked.
In this study, all of the participants took osimertinib as a tablet by mouth once a day. The standard dose of osimertinib was 80 milligrams, also known as “mg”, but the participants could take a lower dose if the study doctors thought they needed to. The participants continued to take osimertinib for as long as the study doctors thought it was helping them or until they left the study.
Researchers look at the results of many studies to decide which treatments work best and are safest. Other studies may provide new information or different results. Always talk to a doctor before making any treatment changes.
There were 3 participants who did not take any study treatment. So, the results below are for the 3,014 participants who took at least 1 dose of study treatment.
The researchers found that the participants lived for an average of 22.8 months after taking osimertinib.
To answer this question, the researchers counted the number of months that the participants lived after their first dose of osimertinib. Then, they calculated the average for all of the participants.
There were 3.0% of participants who had an adverse reaction of special interest. This was 89 out of 3,014 participants.
There were 3.2% of participants who had any serious adverse reaction. This was 95 out of 3,014 participants.
There were 0.6% of participants who stopped taking treatment due to adverse reactions of special interest. This was 18 out of 3,014 participants.
The most common serious adverse reactions were pneumonia and scarring and inflammation in the lungs. The table below shows the serious adverse reactions that happened in 2 or more participants during the study. There were other serious adverse reactions during the study, but these happened in fewer participants.
There were 0.6% of participants who died because of serious adverse reactions. This was 19 out of 3,014 participants.
There were only 2 adverse reactions of special interest that the researchers collected information about:
Having a longer time between heart beats 2.1% (64 participants)
Lung disease or an adverse reaction related to inflammation in the lungs – 0.8% (25 participants) .REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0115
Date of REC Opinion
29 Sep 2015
REC opinion
Further Information Favourable Opinion