Study on Osimertinib for Treating Lung Cancer with EGFR Mutation

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03586453

Provider View

This clinical trial is exploring the use of a targeted therapy called Osimertinib to treat Non-Small Cell Lung Cancer (NSCLC) in patients with a specific genetic mutation known as EGFR.

Patient Parameters

Program Overview

This study is testing a targeted therapy called Osimertinib to see if it can effectively treat Non-Small Cell Lung Cancer (NSCLC) in patients who have a specific genetic mutation in the EGFR gene. This mutation can cause cells to divide abnormally, leading to cancer. Osimertinib is already approved by the FDA for treating this type of lung cancer.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of Osimertinib, a drug that targets a specific genetic mutation in lung cancer. The EGFR gene mutation can cause abnormal cell growth, leading to lung cancer. Osimertinib works by blocking the effects of this mutation, potentially stopping the cancer from growing. The drug is already approved by the FDA for this purpose.

Participants in this study must have advanced Non-Small Cell Lung Cancer (NSCLC) with a specific EGFR mutation. They will receive Osimertinib to see if it helps control their cancer. The study will monitor the safety and effectiveness of the treatment, and participants will need to meet certain health criteria to join.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced Non-Small Cell Lung Cancer (NSCLC) with a specific EGFR mutation.
  • Must have at least one tumor that can be measured by scans.
  • 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 normal organ and bone marrow function based on specific blood tests.
  • Must provide a tumor sample for genetic testing.
  • Must be willing to have a repeat tumor biopsy during the study.
  • Must be at least two weeks past any major surgery.
  • Men must use condoms during sex and avoid fathering a child during and for four months after treatment.
  • Women must use effective birth control during and for six weeks after treatment and must not be pregnant or breastfeeding.
  • Must understand and agree to sign a consent form.
  • Can join the study if they have already started Osimertinib within the first three months of treatment, as long as they meet all other criteria.

Exclusion Criteria

  • Cannot have had previous treatment with other EGFR-targeted therapies, except for Osimertinib in the first three months.
  • Cannot have had chemotherapy or other cancer treatments for advanced NSCLC.
  • Cannot have had recent radiation therapy within two weeks of starting the study.
  • Cannot have uncontrolled brain or spinal cord cancer.
  • Cannot have allergies to Osimertinib or similar drugs.
  • Cannot be taking certain medications that affect how Osimertinib works.
  • Cannot have unresolved side effects from previous treatments.
  • Cannot have had other cancers in the past three years, except for certain skin cancers.
  • Cannot have severe digestive issues that affect medication absorption.
  • Cannot have significant heart problems or other serious health conditions.
  • Cannot have active infections like hepatitis or HIV.
  • Cannot have a specific genetic mutation known as T790M.
  • Cannot be pregnant or breastfeeding, and must use effective birth control if of reproductive potential.

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