Study on Osimertinib With or Without Chemotherapy for First-Line Treatment in Patients with EGFR-Mutated Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04035486

Provider View

This clinical trial is exploring whether combining the drug osimertinib with chemotherapy is more effective than using osimertinib alone for treating advanced non-small cell lung cancer with specific genetic mutations.

Patient Parameters

Program Overview

The purpose of this study is to determine if a combination of the oral medication osimertinib (also known as TAGRISSO®) and chemotherapy is more effective than osimertinib alone in treating non-small cell lung cancer (NSCLC) that is locally advanced or has spread to other parts of the body. Some lung cancers are caused by changes in DNA, and knowing these changes can help doctors choose the best treatment. One such change affects a protein called the Epidermal Growth Factor Receptor (EGFR). Osimertinib targets these EGFR mutations, but over time, the cancer may become resistant to the drug. This study aims to see if adding chemotherapy can delay this resistance and help control the cancer longer. The study will include about 586 patients, with some receiving osimertinib alone and others receiving it with chemotherapy. Participants will be randomly assigned to one of these groups. The study includes a Screening Period, Treatment Period, and Follow-up Period, with about 15 visits in the first year and 4 visits per year after that.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old (20 years old in Japan).
  • Have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC), including mixed types.
  • Have newly diagnosed advanced or metastatic NSCLC that cannot be treated with surgery or radiotherapy.
  • The cancer must have specific EGFR mutations that respond to EGFR-TKI treatment.
  • Have not received any treatment for advanced NSCLC that cannot be cured with surgery or radiotherapy.
  • Have a performance status score of 0 or 1, indicating good overall health.
  • Have a life expectancy of more than 12 weeks.
  • Agree to use contraception during the study and for a period after treatment ends.

Exclusion Criteria

  • Have spinal cord compression or unstable brain metastases, unless treated and stable.
  • Have a history of lung diseases like Interstitial Lung Disease or radiation pneumonitis requiring steroids.
  • Have severe or uncontrolled systemic diseases or active infections like Hepatitis B, C, or HIV.
  • Have heart rhythm abnormalities or prolonged QT interval.
  • Have inadequate bone marrow or organ function based on specific lab tests.
  • Have severe nausea, gastrointestinal diseases, or difficulty swallowing the medication.
  • Have received prior treatment for advanced NSCLC, including chemotherapy or EGFR-TKI.
  • Have had major surgery within 4 weeks before starting the study treatment.
  • Have received extensive radiotherapy recently.
  • Have allergies to the study drug or similar medications.

Locations

FACILITYZIPCITYSTATE
Research Site90706BellflowerCalifornia
Research Site92835FullertonCalifornia
Research Site92093La JollaCalifornia
Research Site90404Santa MonicaCalifornia
Research Site95403Santa RosaCalifornia
Research Site90048West HollywoodCalifornia
Research Site90602WhittierCalifornia
Research Site32804OrlandoFlorida
Research Site33612TampaFlorida
Research Site66160Kansas CityKansas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.