Osimertinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Do I need to stop my current medications for the trial?
The trial does not specify that you must stop all current medications, but you cannot take medications or supplements that strongly affect CYP3A4 enzymes. If you are on such medications, you need to stop them at least 3 weeks before starting the trial. It's best to discuss your current medications with the trial team to ensure they are safe to continue.
Is Osimertinib safe for humans?
Osimertinib has been generally well tolerated in clinical trials for non-small cell lung cancer, with common side effects including diarrhea, rash, dry skin, and nail issues. Serious side effects occurred in 28% of patients, and 5.6% stopped treatment due to these effects, but no new safety concerns were identified in recent studies.12345
What makes the drug Osimertinib unique for treating non-small cell lung cancer?
Osimertinib is unique because it is a third-generation drug specifically designed to target the EGFR T790M mutation, which is often found in patients who have developed resistance to previous treatments. It is taken orally and has shown high response rates in patients with this specific mutation.13456
What data supports the effectiveness of the drug Osimertinib for non-small cell lung cancer?
Osimertinib has shown effectiveness in treating non-small cell lung cancer (NSCLC) with a specific mutation called EGFR T790M, which often develops resistance to earlier treatments. It has been approved by the FDA for patients with this mutation who have progressed after previous therapy, demonstrating its ability to target and manage this type of cancer effectively.34578
Who Is on the Research Team?
Zofia Piotrowska
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive osimertinib orally once daily on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and every 3 months for up to 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
Osimertinib is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
- Metastatic EGFR T790M mutation-positive NSCLC
- Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
- Metastatic EGFR T790M mutation-positive NSCLC
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor