A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Cisplatin in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)
Subjects must meet all of the following criteria to be eligible for the study:
1. Histologically or cytologically documented extensive stage small cell lung cancer.
2. Adults of 18 years of age or older.
3. Performance Status (ECOG) of 0 or 1.
4. FFPE tumor tissue.
5. Adequate organ function:
6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any
7. For women of child-bearing potential, negative serum pregnancy test at screening and
use of physician-approved method of birth control from 30 days prior to the first
study drug administration to 30 days following the last study drug administration or
the last EP in the study, whichever is discontinued last.
8. Male subjects must be surgically sterile or must agree to use physician-approved
contraception during the study and for 30 days following the last study drug
administration or the last EP in the study, whichever is discontinued last.
Subjects who meet any of the following criteria will not be eligible for participation in
1. Limited stage small cell lung cancer appropriate for radical treatment with
2. Prior therapy including radiation, chemotherapy or surgery for newly diagnosed
extensive stage small cell lung cancer.
3. Presence of any serious or uncontrolled illness including, but not limited to:
ongoing or active infection, symptomatic congestive heart failure unstable angina
pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis,
symptomatic pulmonary embolism, and psychiatric illness that would limit compliance
with study requirement.
4. History of myocardial infarction, acute coronary syndromes (including unstable
angina), coronary angioplasty and/or stenting within 6 months prior to the first
administration of study drug.
5. A history of malignancy with the exception of:
1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or
in situ cervical cancer
2. Adequately treated stage I cancer from which the subject is currently in
3. Any other cancer from which the subject has been disease-free for ≥ 3 years
6. Known human immunodeficiency virus (HIV) infection.
7. Females who are pregnant or breastfeeding.
8. Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg
daily for port catheter is allowed)