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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
No Placebo-Only Group

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.
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.
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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best objective response
Secondary study objectives
Incidence of adverse events
Overall survival (OS)
Progression-free survival (PFS)
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (osimertinib)Experimental Treatment6 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 ECHO or MUGA, 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
Echocardiography
2013
Completed Phase 4
~11580
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Biospecimen Collection
2004
Completed Phase 3
~2020
Osimertinib
2017
Completed Phase 4
~1100
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,016,753 Total Patients Enrolled
Zofia PiotrowskaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03191149 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Treatment (osimertinib)
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03191149 — Phase 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03191149 — Phase 2
~4 spots leftby Jun 2025
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