AZD9291 versus Placebo in patients with stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy. - ADAURA

Exclusion Criteria

• 1. Treatment with any of the following:
• - Pre-operative or post-operative or planned radiation therapy for the current lung cancer
• - Pre-operative (neo-adjuvant) platinum based or other chemotherapy
• - Any prior anticancer therapy
• - Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
• - Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug
• - Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
• - Treatment with an investigational drug within five half-lives of the compound or any of its related material.
• 2. Patients who have had only segmentectomies or wedge resections
• 3. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
• 4. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
• 5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
• 6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
• 7. Any of the following cardiac criteria:
• - Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
• - Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
• - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
• 8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
• 9. Inadequate bone marrow reserve or organ function.