A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC

Inclusion Criteria:

Signed Informed Consent Form
Age ≥18 years
Histologically documented recurrent or advanced (Stage IV) NSCLC
Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1
All acute treatmentrelated toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry
Adequate hematologic and end-organ function
Evaluable or measurable disease per RECIST v1.1
For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

Prior treatment with docetaxel for recurrent or advanced NSCLC
More than two regimens of systemic cytotoxic chemotherapy for recurrent or advanced NSCLC
Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
Known hypersensitivity to any component of study treatments
Grade ≥ 2 sensory neuropathy
Uncontrolled seizure disorder or active neurologic disease
Untreated brain metastases
Leptomeningeal disease as a manifestation of cancer
Active infection requiring antibiotics
Bisphosphonate therapy for symptomatic hypercalcemia
Known history of clinically significant liver disease, including active viral hepatitis and cirrhosis
Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
Pregnancy, lactation, or breastfeeding
Known HIV infection
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Concurrent use of therapeutic warfarin
New York Heart Association Classification III or IV (see Appendix E)
Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan

Bone metastases and one of the following:

Prior history of a pathologic fracture
Lytic lesion requiring an impending orthopedic intervention
Lack of treatment with a bisphosphonate or denosumab
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone), and Avandia® (rosiglitzone)
Active treatment with an oral or IV glucocortocoid for ≥4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
Fasting β-CTX of >1000 pg/mL
Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia