AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

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.