Clinical Trial of the Safety and Efficacy of the Addition of Ramucirumab to Nab-paclitaxel in Previously Treated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring ramucirumab, docetaxel Read More

Inclusion Criteria:

All patients must have or meet the following:

• Histologically or cytologically confirmed Stage IV (AJCC 7) non-small cell lung cancer.
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
• Received at least one prior platinum-based chemotherapy for locally advanced or metastatic disease. Prior bevacizumab as 1st line and/or maintenance therapy is allowed. Prior nivolumab is allowed.
• Age ≥18 years.
• ECOG performance status ≤2
• Life expectancy of greater than 12 weeks.
• Adequate liver function
• Adequate hematologic function
• Not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
• Adequate renal function
• Urinary protein of ≤1+ on dipstick or routine urinalysis (UA).
• Adequate coagulation function. Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy.
• Treated and clinically stable brain metastases are allowed.
• Adequate contraceptive use.
• < Grade 2 pre-existing peripheral neuropathy.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients with previous intolerance to ramucirumab.
• Patients who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ramucirumab or nab-paclitaxel.
• Patients with untreated CNS metastases.
• Patients with significant bleeding disorders, vasculitis, or who experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment.
• History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to enrollment.
• Any arterial thromboembolic events, within 6 months prior to enrollment.
• History of uncontrolled hereditary or acquired thrombotic disorder.
• Uncontrolled or poorly-controlled hypertension.
• A serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment.
• Major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment.
• Chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
• Elective or planned major surgery scheduled during the course of the clinical trial.
• Hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon) within 2 months prior to enrollment, or with central or cavitating lesions.
• Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
• History of GI perforation and/or fistulae within 6 months prior to enrollment, or risk factors for perforation.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy
• HIV-positive patients on combination antiretroviral therapy.