Study on Osimertinib for Treating Advanced or Returning Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03191149

Provider View

This clinical trial is testing how well the drug osimertinib works in patients with advanced or returning non-small cell lung cancer that has a specific genetic mutation. The study aims to see if osimertinib can stop the growth of cancer cells by blocking certain enzymes needed for their growth.

Patient Parameters

Program Overview

This study is exploring the effectiveness of osimertinib, a medication that may help stop the growth of tumor cells in patients with advanced or returning non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR exon 20 insertion. The trial will assess how well the drug works, its safety, and how long patients live without the cancer getting worse. Participants will take osimertinib daily and undergo regular scans and blood tests to monitor their progress.

Description

The main goal of this study is to see how well osimertinib works in shrinking tumors in patients with a specific mutation in their lung cancer. Researchers will also look at the safety of taking a 160 mg daily dose of osimertinib and how long patients live without their cancer getting worse or spreading.

Participants will take osimertinib by mouth every day in 21-day cycles, as long as the cancer does not progress or cause unacceptable side effects. Throughout the study, patients will have regular MRI or CT scans and blood tests to check on their health and the cancer's response to the treatment. After finishing the treatment, patients will have follow-up visits for up to five years to monitor their health.

The study will also explore how the cancer responds to the treatment by analyzing tumor DNA in the blood and looking at tumor samples before and after treatment to understand how the cancer might resist osimertinib.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Cancer must be advanced (stage IIIB-IV) or have returned after previous treatment.
  • Must have a specific genetic mutation called EGFR exon 20 insertion in the tumor.
  • Must have measurable cancer that can be tracked with scans.
  • Must have received at least one previous treatment for advanced lung cancer.
  • Must not have taken osimertinib before.
  • Must not have received certain other cancer therapies within the last 6 months.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Must not have active lung diseases or have had recent radiation to the lungs.
  • Must not have active brain metastases or require ongoing steroid treatment for brain metastases.
  • Must have a normal heart function as determined by specific tests.
  • Must not have a history of heart rhythm problems or be taking medications that affect heart rhythm.
  • Must not have another active cancer.
  • Must not be taking other investigational drugs.
  • Must not have uncontrolled illnesses that would interfere with the study.
  • Must not have allergies to osimertinib or similar drugs.
  • Must not be taking medications that interact with osimertinib.
  • Women must not be pregnant or breastfeeding and must use effective birth control during the study.
  • Men must use effective birth control during the study.
  • Must not take other cancer treatments while on the study.

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