Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Brief summary
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
Interventions
DRUGABT-869
12.5 mg ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)
DRUGCarboplatin
Carboplatin (AUC 6 mg/mL/min)
DRUGPaclitaxel
Paclitaxel (200 mg/m2)
Sponsors
Genentech, Inc.
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 18 years of age. * Subject must have cytologically or histologically confirmed non-squamous NSCLC * Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent. * Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only). * Subject has an ECOG Performance Score of 0-1. * Willing to take adequate measures to prevent pregnancy.
Exclusion criteria
* The subject has NSCLC with a predominant squamous cell histology * Subject has hypersensitivity to paclitaxel. * Subject has received any anti-cancer therapy for treatment of NSCLC. * Subject has received radiation therapy within 21 days of Study Day 1. * Subject has had major surgery within 21 days. * Subject has untreated brain or meningeal metastases. * Subject is receiving therapeutic anticoagulation therapy. * Subject has a central thoracic tumor lesion as defined by location within the hilar structures. * Subject has proteinuria CTC Grade \> 1 at baseline. * Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding. * The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) \> 90 mm Hg or systolic BP \> 140 mm Hg. * The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1. * The subject has a documented left ventricular (LV) ejection fraction \< 50%. * The subject has known autoimmune disease with renal involvement (i.e., lupus). * The subject is receiving combination anti-retroviral therapy for HIV. * The subject has clinically significant uncontrolled condition(s). * The subject has a history of another active cancer within the past 5 years. * The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption. * The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities. * The subject is pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | Disease Progression |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response | Disease Progression |
| Survival Rate | 12 Months |
Countries
Australia, Brazil, Czechia, Russia, Singapore, United States
Outcome results
None listed