Study on Osimertinib and Gefitinib for Untreated Advanced EGFR Mutant Lung Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT03122717

Provider View

This clinical trial is exploring the use of two drugs, Osimertinib and Gefitinib, as a potential treatment for patients with advanced Non-Small Cell Lung Cancer (NSCLC) that has a specific EGFR mutation and has not been treated with EGFR inhibitors before.

Patient Parameters

Program Overview

The study aims to test a combination of two drugs, Osimertinib and Gefitinib, to see if they can effectively treat Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. Both drugs are already approved for use separately, but this study is looking at how they work together in patients who have not received any EGFR inhibitor treatment before.

Description

This is a Phase I clinical trial, which means it is focused on testing the safety of the drug combination and finding the right dose for future studies. Both Osimertinib and Gefitinib are approved by the FDA for treating lung cancer with an EGFR mutation, but they have not been approved to be used together.

The study is for patients who have just been diagnosed with non-small cell lung cancer that has a mutation in the EGFR gene. Normally, cancer cells grow uncontrollably due to changes in certain genes, like EGFR. Drugs called EGFR inhibitors can help control this growth, but over time, the cancer may become resistant to these drugs.

Currently, patients with this type of lung cancer are treated with a single EGFR inhibitor. Osimertinib is usually given when the cancer becomes resistant to other EGFR inhibitors like Gefitinib. However, recent studies suggest that using Osimertinib as the first treatment can be effective, and combining it with Gefitinib might prevent resistance from developing.

This study will test two ways of combining these drugs: taking both together daily or alternating between them every four weeks. The goal is to find the best way to use these drugs together and to see how well they control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced Non-Small Cell Lung Cancer (NSCLC) with a specific EGFR mutation.
  • Must have measurable cancer that can be tracked with scans.
  • Must not have received any previous EGFR-targeted therapy or chemotherapy for advanced cancer.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have a life expectancy of more than 12 weeks.
  • Must have normal organ and blood function based on specific tests.
  • Must provide a tumor sample for genetic testing.
  • Must be at least 4 weeks post-major surgery and 2 weeks post-radiation.
  • Must agree to use contraception during and after the study.
  • Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Previous treatment with EGFR-targeted therapy or other similar drugs.
  • Recent radiotherapy within 2 weeks before starting the study.
  • Uncontrolled brain or spinal cord cancer spread.
  • Allergic reactions to similar drugs.
  • Use of certain medications that affect drug metabolism.
  • Unresolved side effects from previous treatments.
  • Recent history of other cancers, except for certain skin cancers.
  • Medical conditions affecting the heart, lungs, or ability to take oral medication.
  • Active infections like hepatitis or HIV.
  • Use of blood thinners like warfarin.
  • Presence of a specific EGFR mutation (T790M) in blood tests.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
Beth Israel Deaconess Medical Center02215BostonMassachusetts
Dana Farber Cancer Institute02215BostonMassachusetts

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