A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

Inclusion Criteria:

- Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent
non-small cell lung cancer (NSCLC)

- PD-L1-positive status as determined by an IHC assay performed by a central laboratory

- ECOG Performance Status of 0 or 1

- Life expectancy >= 12 weeks

- Measurable disease, as defined by RECIST v1.1

- Adequate hematologic and end organ function

Exclusion Criteria:

- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within
3 weeks prior to initiation of study treatment; the following exceptions are allowed:

- Hormone-replacement therapy or oral contraceptives Tyrosine kinase inhibitors
approved for treatment of NSCLC discontinued > 7 days prior to Cycle 1 Day 1

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to enrollment

- Known CNS disease, including treated brain metastases: Cohorts 1 and 2

- Patients with a history of treated asymptomatic brain metastases are allowed in
Cohort 3

- Leptomeningeal disease

- Uncontrolled tumor-related pain

- Uncontrolled hypercalcemia