Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed, stage IV or recurrent non-squamous NSCLC - No prior chemotherapy, molecularly-targeted therapy, or immunotherapy - Measurable or non measurable lesion per RECIST version 1.1 - ECOG performance status of 0 or 1 - Patients must be 18 years of age or older at the time informed consent is obtained
Exclusion criteria
Exclusion criteria: - Untreated or symptomatic central nervous system metastases - History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization - Prior targeted therapies - Any anticoagulation therapy within 7 days prior to randomization. - History of arterial or venous thrombosis within 12 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), objective response rate (ORR), duration of response, incidence of adverse events and abnormalities in clinical laboratory data, pharmacokinetics of AMG 706 and its metabolites | — |