A Phase III, Randomized, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor

Contact:

NCT Number:

Protocol:

AAAT5068

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

The purpose of this study is to see whether the medication osimertinib (TAGRISSOTM) alone or when used in combination with chemotherapy is more effective than chemotherapy alone for the treatment of early stage Non-Small Cell Lung Cancer prior to surgery. Osimertinib is an EGFR TKI therapy that targets EGFR mutations. When a tumor is found to have this type of mutation, there is a class of drugs known as EGFR tyrosine kinase inhibitors (TKIs) which target the mutation to treat the patient.

Are you Eligible? (Inclusion Criteria)

  • Are you at least 18 years old?
  • Do you have documented non-squamous Non-Small Cell Lung Cancer with completely resectable (Stage II -IIIB N2) disease?
  • Do you have a life expectancy of greater than 6 months?
  • You do not have a history of allogeneic organ transplantation

Specialty Area(s)

Lung cancer

Principal Investigator

Profile Headshot
  • Clinical Director, Thoracic Medical Oncology Service

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032