Study on Osimertinib and Cyclosporine A to Improve Treatment in Advanced Non-Small Cell Lung Cancer

Sponsor: NYU Langone Health

Sponsor score: 40

ClinicalTrials ID:NCT07874490

This clinical trial is exploring whether adding cyclosporine A to the standard treatment with osimertinib can enhance its effectiveness in treating advanced non-small cell lung cancer (NSCLC) with specific genetic mutations.

Patient Parameters

Program Overview

This study is testing a new approach to treating advanced non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. The trial will compare the effects of using the drug osimertinib alone versus in combination with cyclosporine A. Participants will first receive osimertinib for three weeks. Those whose cancer still shows signs of activity will be randomly assigned to continue with just osimertinib or to add cyclosporine A to their treatment. The study will monitor how well the treatments work by checking blood samples and performing regular scans.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to give informed consent.
  • Have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations, verified by standard testing.
  • Either have not started EGFR TKI therapy or may have started osimertinib within three weeks of meeting the study criteria, with no prior chemotherapy for metastatic disease.
  • Have at least one measurable tumor that has not been treated with radiation.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function.
  • Agree to use effective birth control if there is a potential for pregnancy.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received radiation therapy within one week before starting the study treatment, unless already on osimertinib.
  • Have had major surgery within two weeks before starting the study treatment, unless already on osimertinib.
  • Have taken an investigational drug recently.
  • Are taking medications or supplements that strongly affect liver enzymes (CYP3A4).
  • Have severe or uncontrolled health conditions, such as high blood pressure or bleeding disorders.
  • Have active infections like hepatitis B, hepatitis C, or HIV.
  • Have digestive issues that prevent taking the study drugs.
  • Have heart rhythm problems or a family history of sudden death.
  • Have a history of lung diseases that required steroid treatment.
  • Have allergies to the study drugs or similar medications.
  • Have a history of autoimmune diseases, except for Hashimoto's thyroiditis.

Locations

FACILITYZIPCITYSTATE
NYU Langone Heath10016New YorkNew York

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