The ADAURA Study
A phase III, double-blind, randomized, placebo-controlled multi-center study to assess the efficacy and safety of AZD9291 versus placebo in patients with epidermal growth factor receptor mutation positive stage IB-IIIA non-small cell lung carcinoma, following complete tumor resection with or without adjuvant chemotherapy (ADAURA).
This study is being carried out to see if AZD9291 is effective in treating early stage lung cancer after a complete surgical removal of the tumor and if so, how it compares with placebo. Patients may have received standard chemotherapy following surgery, and prior to participating in this study. This study will also measure levels of drug in the blood and see how well it is tolerated. In order to be eligible for the study, the tumor must be confirmed to have one of the two most common EGFR mutations.
In order to participate you must meet the following criteria:
- Have histologically confirmed primary stage IB-IIIA non-squamous NSCLC.
- Have EGFR mutation positive for Ex19del and/or L858R, either alone or in combination with other EGFR mutations.
- Have complete surgical resection of primary NSCLC. Margins must be negative for tumor.
- Have complete recovery from surgery, at least 4 weeks between surgery and start of treatment.
- Have no more than 10 weeks from surgery to start of treatment with no adjuvant chemotherapy.
- Have no more than 26 weeks from surgery to start of treatment with adjuvant chemotherapy.
- Have ECOG performance status of 0-1.
- Have imaging of brain done prior to randomization if not done prior to surgery.
You will be excluded from the study if any of the following criteria apply to you:
- Have any radiation therapy for current lung cancer.
- Have neo-adjuvant platinum based or other chemotherapy.
- Have had prior treatment with EGFR-TKI.
- Have had major surgery (including primary tumor surgery) within 4 weeks of first dose of study drug.
- Have segmentectomies or wedge resections.
- Have a history of other malignancies.
- Have any severe or uncontrolled systemic diseases including hypertension, hepatitis B, hepatitis C, HIV, active infections.
- Have chronic gastrointestinal disease, inability to swallow drug, history of significant bowel resection.
- Have caardiac criteria such as prolonged QT interval, arrhythmias, or conduction disorders.
- Have a history of interstitial lung disease.
This is a partial list of inclusion and exclusion criteria.