T790M Mutation Positive 2nd Line STandard of cAre Registry

The study is an observational prospective cohort study that plans to enroll approximately
200 patients worldwide. There are Epidermal Growth Factor Receptor (EGFR) mutations known to
be associated with EGFR-targeted TKI sensitivity ( Ex19Del, L858R, L861Q, and G719X).
Further tests on biopsied tissue or cytology at progression after treatment with an approved
EGFR targeted TKI are used to determine positivity to T790M mutation. Primary objectives of
the study are :

- To estimate overall survival

- To estimate disease progression (as assessed and defined by physician)

- To estimate time on treatment by line of therapy

- To describe time to subsequent therapies (or death)

- To describe healthcare resource utilization patterns

- To capture patient reported symptoms, functioning, and health-related quality of life
(HRQoL) data using European Organization for Research and Treatment of Cancer Quality
of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for
Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items
(EORTC QLQ-LC13)

- To describe the use of pemetrexed + cisplatin/carboplatin as the 2nd line treatment

- To describe treatment patterns for 3rd line treatment and beyond

Inclusion Criteria:

- Provision of signed and dated written informed consent prior to any study specific
procedure.

- Patients with histologically- or cytologically-documented NSCLC who present with
Stage IIIB/ Stage IV disease.

- Evidence of radiological disease progression following 1st line treatment for
advanced/metastatic NSCLC with an approved EGFR-targeted TKI monotherapy without any
additional concurrent NSCLC treatment. Chemotherapy received in the adjuvant setting
is permitted.

- Patients prescribed platinum based doublet chemotherapy (pemetrexed +
cisplatin/carboplatin) for 2nd line treatment of NSCLC. Treatment must have been
selected by physician as part of routine standard of care, prior to confirming
eligibility for the study. Patient must be enrolled into the study within two cycles
of beginning treatment. Treatment must be given in accordance with local prescribing
information.

- Confirmation prior to enrolment into the study that the tumour harbours the following
EGFR mutations known to be associated with EGFR-targeted TKI sensitivity: Ex19Del,
L858R, L861Q, and G719X.

- Patients must have had confirmation that tumour is T790M mutation positive from a
biopsy or cytology sample taken after confirmed disease progression on 1st line
treatment with an approved EGFR-targeted TKI.

- WHO performance status 0-1 with no deterioration over the previous 2 weeks and a
minimum life expectancy of 12 weeks.

Exclusion Criteria:

- Treatment with any of the following:

- Prior treatment with more than one line of treatment for advanced NSCLC.

- Major surgery (excluding placement of vascular access) within 4 weeks prior to
enrolment.

- Palliative radiotherapy with a limited field of radiation within 1 week prior to
enrolment, 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 prior to enrolment.

- Spinal cord compression or brain metastases unless asymptomatic, stable and not
requiring steroids for at least 4 weeks prior to enrolment.

- Patients who are known to be entering an alternative interventional clinical study at
the time of enrolment into this study will be excluded. However, inclusion in this
study does not preclude participation in any other clinical study after enrolment.
Patients who participate in clinical studies after enrolment into this study will be
followed to the extent possible as permitted by the sponsor of that clinical study.

- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or
staff at the site).

- Judgment by the physician that the patient should not participate in the study if the
patient is unlikely to comply with procedures, restrictions, and requirements.