EGFR T790M Mutation Positive NSCLCNCT02451852
AZD9291 US Expanded Access Program
A study testing AZD9291 in people with EGFR T790M Mutation Positive NSCLC, run by AstraZeneca at 32 sites in United States.
Trial summary
To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- EGFR T790M Mutation Positive NSCLC
- What is being tested?
- AZD9291
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 32 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any treatment protocol-specific procedures
- Patients aged at least 18 years
- Locally advanced or metastatic EGFRm NSCLC, not amenable to curative surgery or radiotherapy with confirmation of the presence of the T790M mutation
- Two lines of prior therapy including at least one EGFR TKI
- World Health Organization (WHO) performance status 0-2.
- Females of child-bearing potential must use adequate contraceptive measures, not be breast-feeding and have negative pregnancy test prior to start of dosing.
- Males patients should be willing to use barrier contraception.
Who cannot join
- Previous treatment with AZD9291
- Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of CYP3A4
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the clinician's opinion would significantly alter the risk/benefit balance, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Patients with symptomatic CNS metastases who are neurologically unstable
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- Any of the following cardiac criteria:
Show all 12Show fewer
- Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
- Any unresolved toxicity from prior therapy Common Terminology Criteria for Adverse Events (CTCAE) > grade 3 at the time of starting treatment in the access program
- History of hypersensitivity to AZD9291 (or drugs with a similar chemical structure or class to AZD9291) or any excipients of these agents
- Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to access program entry
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Research Site
Anaheim, California
Research Site
Athens, Georgia
Research Site
Austin, Texas
Research Site
Beverly Hills, California
Research Site
Boca Raton, Florida
Research Site
Boston, Massachusetts
Research Site
Buffalo, New York
Research Site
Burbank, California
Research Site
Charlotte, North Carolina
Research Site
Chevy Chase, Maryland
Research Site
Chicago, Illinois
Research Site
Columbus, Ohio
Research Site
Dallas, Texas
Research Site
Detroit, Michigan
Research Site
Fairfax, Virginia
Research Site
Fleming Island, Florida
Research Site
Fresh Meadows, New York
Research Site
Honolulu, Hawaii
Research Site
Lacey, Washington
Research Site
Lansing, Michigan
Research Site
Lincoln, Nebraska
Research Site
Manchester, Connecticut
Research Site
Mineola, New York
Research Site
New York, New York
Research Site
Paramus, New Jersey
Research Site
Rochester, Minnesota
Research Site
Santa Barbara, California
Research Site
Santa Rosa, California
Research Site
Seattle, Washington
Research Site
Sioux Falls, South Dakota
Research Site
Warrenton, Virginia
Research Site
Winston-Salem, North Carolina
About this study
Official title: A Multi-center, AZD9291 Expanded Access Program for the Treatment of Patients With Advanced/Metastatic EGFR T790M Mutation-positive Non-small Cell Lung Cancer (NSCLC) Who Have Received Prior EGFR TKI Therapy
To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.
Read the detailed description
- This is a multi-center, AZD9291 expanded access protocol for the treatment of adult patients with advanced/metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have received prior EGFR TKI therapy and at least one additional line of therapy (≥ 3rd line). Local testing is accepted for confirmation of T790 mutation status. Eligible patients will be enrolled to receive AZD9291 (80mg orally, once daily) for as long as the access program remains open and they are continuing to show clinical benefit, as judged by the treating physician
- Conditions
- EGFR T790M Mutation Positive NSCLC
- Being tested
- AZD9291
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9291Drug
AZD9291 80mg tablet once daily, open label
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR T790M Mutation Positive NSCLCStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451852
- Sponsor's protocol ID
- D5160C00021
- Status last verified
- Jul 2016
- First submitted
- 20 May 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, AZD9291 Expanded Access Program for the Treatment of Patients With Advanced/Metastatic EGFR T790M Mutation-positive Non-small Cell Lung Cancer (NSCLC) Who Have Received Prior EGFR TKI Therapy
- ClinicalTrials.gov ID
- NCT02451852
- Acronym / sponsor ID
- D5160C00021
- Conditions
- EGFR T790M Mutation Positive NSCLC
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.
Detailed description
- This is a multi-center, AZD9291 expanded access protocol for the treatment of adult patients with advanced/metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have received prior EGFR TKI therapy and at least one additional line of therapy (≥ 3rd line). Local testing is accepted for confirmation of T790 mutation status. Eligible patients will be enrolled to receive AZD9291 (80mg orally, once daily) for as long as the access program remains open and they are continuing to show clinical benefit, as judged by the treating physician
Study design
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any treatment protocol-specific procedures
- Patients aged at least 18 years
- Locally advanced or metastatic EGFRm NSCLC, not amenable to curative surgery or radiotherapy with confirmation of the presence of the T790M mutation
- Two lines of prior therapy including at least one EGFR TKI
- World Health Organization (WHO) performance status 0-2.
Key exclusion criteria (12 listed)
- Previous treatment with AZD9291
- Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of CYP3A4
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the clinician's opinion would significantly alter the risk/benefit balance, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Patients with symptomatic CNS metastases who are neurologically unstable
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9291AZD9291 80mg tablet once daily, open label | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AZD9291 in people with EGFR T790M Mutation Positive NSCLC, run by AstraZeneca at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.