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Keep this study
Lead
Amgen
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
Age
18–95
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
