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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Biospecimen Collection

2004

Completed Phase 3

~2030