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Tyrosine Kinase Inhibitor
Osimertinib for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Zofia Piotrowska
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trialstudies a drug to help stop the growth of advanced or recurring non-small cell lung cancer with an EGFR mutation.
Who is the study for?
Adults with stage IIIB-IV or recurrent non-small cell lung cancer and a specific mutation (EGFR exon 20 insertion) can join this trial. They must have had prior therapy, no other active cancers, controlled heart conditions, and not be on certain medications that affect the drug being tested. Pregnant or breastfeeding women are excluded, as well as those with symptomatic brain metastases.Check my eligibility
What is being tested?
The trial is testing Osimertinib's effectiveness in treating advanced lung cancer with a particular genetic change. It involves collecting biological samples and using imaging tests like CT scans and MRIs to monitor the tumor's response to treatment.See study design
What are the potential side effects?
Osimertinib may cause side effects such as diarrhea, rash, dry skin, nail changes, mouth sores, reduced appetite, coughing up blood or blood clots in your veins or arteries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one treatment for my advanced lung cancer.
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I have no allergies to osimertinib or similar drugs.
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My bilirubin levels are within the normal range, or slightly higher if I have liver issues.
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I have never stopped a medication due to it causing heart rhythm problems.
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I am not taking any other cancer treatments while on this study.
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I have been diagnosed with non-small cell lung cancer.
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My cancer is advanced and cannot be treated with a combination of therapies.
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My cancer can be measured and was checked within the last 4 weeks.
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I have never taken osimertinib.
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I am not taking any medications known to cause heart rhythm problems.
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I do not have serious heart rhythm problems or a family history of sudden heart issues.
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I have heart failure symptoms that affect my daily activities.
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I can swallow pills and don't have chronic stomach issues affecting drug absorption.
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My heart health does not meet any exclusion criteria.
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My heart's pumping ability is normal based on a recent heart scan.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best objective response
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue
Characterization of molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (ctDNA)
Identification of resistance mechanisms to osimertinib through post-progression tumor biopsies and ctDNA
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (osimertinib)Experimental Treatment4 Interventions
Patients receive osimertinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI or CT with contrast and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,885 Total Patients Enrolled
Zofia PiotrowskaPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking, nor can stop taking, strong CYP3A4 inducers 3 weeks before the study.I have had at least one treatment for my advanced lung cancer.Your kidney function is within the normal range based on recent tests.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have no allergies to osimertinib or similar drugs.Your hemoglobin level is at least 9.0 grams per liter within the last 4 weeks before joining the study.Your white blood cell count is at least 3,000 per microliter within the last 4 weeks before joining the study.Your blood has enough infection-fighting white blood cells.Your platelet count is at least 100,000 per microliter within the last 4 weeks before joining the study.My bilirubin levels are within the normal range, or slightly higher if I have liver issues.My liver function tests are within the required range.Your average QT interval on three ECG tests is longer than 470 milliseconds.I have never stopped a medication due to it causing heart rhythm problems.I am not taking any other cancer treatments while on this study.I don't have severe side effects from previous treatments, except for hair loss or mild nerve pain from platinum-based therapy.I am not pregnant or breastfeeding and have tested negative for pregnancy if capable of bearing children.I can receive necessary supportive care medications during the trial.I am aware of how my current medications might interact with the trial treatment.I have been diagnosed with non-small cell lung cancer.My cancer is advanced and cannot be treated with a combination of therapies.My cancer can be measured and was checked within the last 4 weeks.I have never taken osimertinib.I haven't had lung radiation in the last 4 weeks or any other recent radiation that conflicts with starting treatment.I am not taking any medications known to cause heart rhythm problems.I have heart failure symptoms that affect my daily activities.I can swallow pills and don't have chronic stomach issues affecting drug absorption.I can continue my regular medications except for strong CYP3A4 inducers and must be cautious with certain drugs while on osimertinib.I am taking the lowest possible dose of rosuvastatin and monitoring my cholesterol and muscle health closely.I am using or willing to use effective birth control during and after the study as required.I haven't had treatments targeting PDL1, PD1, or CTLA4 in the last 6 months.I do not have serious heart rhythm problems or a family history of sudden heart issues.I do not have an active second cancer.I am on warfarin and get regular checks for blood clotting times.My heart health does not meet any exclusion criteria.I do not have active lung conditions that affect my daily activities or needed treatment.My heart's pumping ability is normal based on a recent heart scan.I am fully active and can carry on all my pre-disease activities without restriction.I am 18 years old or older.My cancer has an EGFR exon 20 mutation.I don't have active brain cancer symptoms and haven't needed to change my brain cancer medication dose for two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (osimertinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies left in this clinical experiment for participants?
"Affirmative. Clinicaltrials.gov's records show that recruitment for this research is ongoing, beginning with it's initial post on April 5th 2018 and most recently updated on December 10th 2022. The investigation requires 20 people to be recruited from 100 medical facilities."
Answered by AI
How extensive is the current participant pool for this clinical trial?
"20 participants, who satisfy the necessary requirements, are needed to complete this trial. People can join from two sites: Illinois CancerCare - Washington in Washington, Iowa or Illinois CancerCare-Dixon in Dixon, Kansas."
Answered by AI
Is this an unprecedented research project?
"Currently, 102 trials are underway for osimertinib in 1061 cities across 51 nations. This medication's evaluation and testing first began in 2013 under the auspices of AstraZeneca with 603 participants. From this point up until now, 31 such studies have been successfully concluded."
Answered by AI
Has the FDA certified osimertinib for therapeutic use?
"The safety rating of osimertinib is a 2 due to limited evidence in Phase 2 trials that suggests relative security, however there are no results yet indicating its efficacy."
Answered by AI
Could you please provide a synopsis of the past research done related to osimertinib?
"Currently, there are 102 studies regarding osimertinib in progress with 17 of those trials having reached Phase 3. Most of these investigations into this treatment occur at the Uniondale site; however, 5,031 locations worldwide run clinical experiments for osimertinib."
Answered by AI
In which sites can this clinical experiment be accessed?
"A multitude of facilities are on-board to facilitate this medical trial, such as Illinois CancerCare - Washington in Washington, Iowa; Illinois CancerCare-Dixon in Dixon, Kansas; and Jennie Edmundson Memorial Hospital in Council Bluffs, Michigan."
Answered by AI
Who else is applying?
What site did they apply to?
Temple University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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