MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC)

In Escalation phase: MEDI4736 and gefitinib in NSCLC subjects In Expansion phase: Subjects
with EGFR mutation positive locally advanced or metastatic NSCLC will be enrolled in
expansion arms. Initiation of expansion arms with the recommended dose of MEDI4736 in
combination with gefitinib will be based on an adequate safety and tolerability profile of
the combination from the escalation phase.

Key Inclusion Criteria:

1. Provision of signed and dated, written informed consent

2. Male or female aged 18 years and older.

3. Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC
subjects who have either failed to respond or relapsed following any line of standard
treatment, were unable to tolerate, or were not eligible for standard treatment b. In
the expansion phase, histologically or cytologically confirmed locally advanced or
metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and
sensitive to EGFR TKIs therapy

4. a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For
Expansion Phase: At least one measurable lesion.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- For Japan Escalation - the same as the global escalation I/E criteria except
patients must be EGFR mutation positive

Key Exclusion Criteria:

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
treatment.

2. Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28
days of the first dose of study treatment

3. Inadequate bone marrow reserve or organ function