The Study to Assess Efficacy and Safety of Adjuvant Osimertinib vs Placebo in Participants with EGFR Mutation with NSCLC

Clinical Trial Title

A Phase III, Double-blind, Randomized, Placebo-Controlled, International Study to assess Efficacy and Safety of Adjuvant Osimertinib vs Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 NSCLC, following Complete Tumour Resection (ADAURA2)

National Clinical Trial Number:

NCT05120349

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Protocol Description:

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Have stage IA2 or IA3 disease, based on TNM8 classification.
  • Have ompleted surgical resection (R0) of the primary NSCLC by lobectomy, segmentectomy or sleeve resection.
  • Have complete recovery from surgery at the time of randomization. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomization for participants.

You will be excluded from the study if any of the following criteria apply to you:

  • Have mixed small cell and non-small cell cancer history.
  • Have incomplete (R1/R2) resection, or who have undergone pneumonectomy, bilobectomy or only wedge resection.
  • Have any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and HIV.
  • Have a history of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Mary Jo Fidler, MD

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Location

RUSH University Medical Center

Location

RUSH University Medical Center

1620 W Harrison St
Chicago, IL 60612

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