Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as
dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer
(NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin

Inclusion Criteria:

- Histologically confirmed, unresectable stage IV non-squamous non small cell lung
cancer (NSCLC)

- Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with
modifications

- Adequate hematological, renal, and hepatic function, normal coagulation profile,
calculated CrCL ≥ 45 mL/min

- Other criteria may apply

Exclusion Criteria:

- Any prior chemotherapy or targeted therapy for non-squamous NSCLC

- Subjects with adenosquamous histology or any histology subtype containing greater
than 10% squamous cells

- Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to
treatment with a tyrosine kinase inhibitor (TKI)

- Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations

- History or presence of central nervous system metastases

- Central (chest) radiation therapy within 28 days prior to enrollment/randomization,
radiation therapy to any other site(s) within 14 days prior to
enrollment/randomization

- History of pulmonary hemorrhage or gross hemoptysis within 6 months

- History of arterial or venous thromboembolism within 12 months

- History of clinically significant bleeding within 6 months

- Clinically significant cardiovascular disease within 12 months

- Other criteria may apply