Trial of Poor Performance Status Patients (ToPPS)

Inclusion Criteria

• Patients must be >=18 years of age.
• Non-squamous NSCLC (adenocarcinoma or large cell carcinoma). Mixed tumors with small cell anaplastic elements are not eligible. Mixed tumors with squamous histology are acceptable as long as the squamous element is not the dominant histology.
• Unresectable stage IIIB or stage IV disease. Stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions).
• ECOG performance status of 2.
• No prior systemic therapy for stage IIIB or stage IV lung cancer.
• Life expectancy of at least 12 weeks.
• Patients must have measurable disease per RECIST version 1.1 (see Section 8).
• Laboratory values as follows:
• Absolute neutrophil count (ANC) ≥1500/μL
• Hemoglobin (Hgb) ≥10 g/dL
• Platelets ≥100, 000/μL (≤7 days prior to treatment)
• AST or ALT and alkaline phosphatase (ALP) must be 150 mmHg and /or diastolic blood pressure >100 mmHg while on antihypertensive medications).
• New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF) (see Appendix C).
• Serious cardiac arrhythmia requiring medication.
• Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of treatment.
• History of stroke or transient ischemic attack ≤ 6 months prior to beginning treatment.
• Any prior history of hypertensive crisis or hypertensive encephalopathy.
• History of abdominal fistula or gastrointestinal perforation ≤ 6 months prior to Day 1 of beginning treatment.
• Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
• Use of any non-approved or investigational agent ≤ 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
• Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.