Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer

For inclusion in the study patients should fulfil the following criteria:

1. Male or female, aged at least 18 years.

2. Able to eat a high-fat meal within a 30-minute period, as provided by the study site.

3. Histologically or, where appropriate, cytologically confirmed NSCLC.

4. Radiological documentation of disease progression while on a previous continuous
treatment with an EGFR TKI. In addition, other lines of therapy may have been given.
All patients must have documented radiological progression on the last treatment
administered prior to enrolling in the study.

5. Confirmation that the tumour harbours an EGFR mutation known to be associated with
EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).

6. ECOG performance status 0-1 with no deterioration over the previous 2 weeks.

7. Patients must have a life expectancy of ≥12 weeks, as estimated at the time of
screening.

8. Females should be using adequate contraceptive measures and must have a negative
pregnancy test prior to start of dosing if of child-bearing potential, or must have
evidence of non-child-bearing potential by fulfilling one of the following criteria
at screening: Post-menopausal defined as aged more than 50 years and amenorrhoeic for
at least 12 months following cessation of all exogenous hormonal treatments; Women
under 50 years old would be considered post-menopausal if they have been amenorrhoeic
for 12 months or more following cessation of exogenous hormonal treatments and with
luteinizing hormone and follicle stimulating hormone levels in the post-menopausal
range for the institution; Documentation of irreversible surgical sterilisation by
hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal
ligation.

9. Male patients should be willing to use barrier contraception, ie, condoms, until 6
months after last study drug is taken.

Patients should not enter the study if any of the following exclusion criteria are
fulfilled:

1. Participation in another clinical study with an IP during the last 14 days (or a
longer period depending on the defined characteristics of the agents used).

2. Treatment with any of the following: Treatment with an EGFR TKI w/in 8 days or
approximately 5x half-life, whichever is the longer, of the first dose of study
treatment; Any cytotoxic chemotherapy, investigational agents or other anticancer
drugs w/in 14 days of the first dose of study treatment; Major surgery (excluding
placement of vascular access) within 4 weeks of the first dose; Radiotherapy with a
limited field of radiation for palliation within 1 week of the first dose of study
treatment, with the exception of patients receiving radiation to more than 30% of the
bone marrow or with a wide field of radiation which must be completed within 4 weeks
of the first dose of study treatment; Patients currently receiving (or unable to stop
use prior to receiving the first dose of study treatment) medications or herbal
supplements known to be potent inhibitors of CYP2C8 and of CYP3A4 (at least 1 week
prior) and potent inducers of CYP3A4 (at least 3 week prior). All patients must try
to avoid concomitant use of any medications, herbal supplements and/or ingestion of
foods with known inducer/inhibitory effects on CYP3A4, CYP2C8, and/ or CYP1A2.

3. Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange
marmalade, or other products containing grapefruit or Seville oranges within 7 days
of the first administration of the IP until the end of Part A.

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. Patients unable to fast for up to 14 hours.

6. Spinal cord compression or brain metastases unless asymptomatic, stable and not
requiring steroids for at least 4 weeks prior to start of study treatment.

7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled
hypertension and active bleeding diatheses, which in the Investigator's opinion makes
it undesirable for the patient to participate in the study or which would jeopardise
compliance with the protocol, or active infection including hepatitis B, hepatitis C
and human immunodeficiency virus. Screening for chronic conditions is not required.

8. Patients with type I diabetes.

9. Patients unable to swallow orally administered medication or patients with
gastrointestinal disorders or significant gastrointestinal resection likely to
interfere with the absorption of AZD9291.

10. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required
steroid treatment, or any evidence of clinically active ILD.

11. Women who are breastfeeding.

12. Patients with a known hypersensitivity to AZD9291

13. Inadequate bone marrow reserve or organ function as demonstrated by any of the
following laboratory values: Absolute neutrophil count (ANC) <1.5 x 109/L; Platelet
count <100 x 109/L; Haemoglobin <90 g/L; ALT >2.5 x the institutional ULN if no
demonstrable liver metastases or >5 x institutional ULN in the presence of liver
metastases; AST >2.5 x institutional ULN if no demonstrable liver metastases or >5 x
institutional ULN in the presence of liver metastases; Total bilirubin >1.5 x
institutional ULN if no liver metastases or >3 x institutional ULN in the presence of
documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases;
Creatinine >1.5 x institutional ULN concurrent with creatinine clearance <50 mL/min
(measured or calculated by Cockcroft-Gault formula); confirmation of creatinine
clearance is only required when creatinine is >1.5 x institutional ULN.

14. Any of the following cardiac criteria: Mean resting corrected QT interval corrected
for heart rate using Fridericia's correction factor (QTcF) >470 msec obtained from 3
ECGs; Any clinically important abnormalities in rhythm, conduction or morphology of
resting ECG eg, complete left bundle branch block, third degree heart block, second
degree heart block, PR interval >250 msec; Any factors that increase the risk of QTc
prolongation or risk of arrhythmic events such as heart failure, hypokalaemia,
congenital long QT syndrome, family history of long QT syndrome or unexplained sudden
death under 40 years of age or any concomitant medication known to prolong the QT
interval.

15. For optional genetic research: Previous allogenic bone marrow transplant or
non-leukocyte depleted whole blood transfusion within 120 days of the date of the
genetic sample collection.