Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer

Inclusion Criteria

• •1. Patient able and willing to comply with study procedures as per protocol, including the geriatric assessment at the time of study enrollment.
• •2. Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.
• •3. Patients must have histological or cytological confirmed primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous, or unspecified). Disease must be stage IV Non-Small Cell Lung Cancer (NSCLC). Disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation. Primary or metastatic site for biopsy is allowed
• •4. Patients may have measurable or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease. Measurable disease must be assessed within 30 days prior to registration per response evaluation criteria in solid tumors (RECIST) v1.1. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non- measurable disease must be assessed within 30 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form.
• •5. Prior chemotherapy for curative intent is permitted providing the cytotoxic chemotherapy was completed ≥12 months prior to enrollment. Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 30 days prior to registration. Patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day. Any radiation therapy completed prior to chemotherapy, except gamma-knife radiosurgery, 1 week prior to chemotherapy.
• •6. Age \>70 years of age at time of signing of the informed consent form.
• •7. Life expectancy of greater than 12 weeks.
• •8. ECOG performance status 0-2 (See Appendix A)
• •9. Patients must have a comprehensive geriatric assessment and chemotherapy toxicity assessment score between 7-17 (See Appendix B, D)
• •10. Patients must have normal organ and marrow function as defined below:
• •* Leukocytes \>3,000/mcL
• •* ANC \> 1,500 cells/mm3Hemoglobin \> 9.0g/dL
• •* Platelets \>100,000 cells/mm3
• •* Total bilirubin \< 1.5 mg/dL (unless there is a known history of Gilberts Syndrome).
• •* AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
• •* Alkaline phosphatase \< 2.5 X upper limit of normal in the absence of liver or bone metastasis, or ≤ 5.0 × upper limit of normal range if bone or liver metastases
• •* Creatinine clearance \>25 mL/min or creatinine \<1.5 mg/dL
• •12. Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection.
• •13. No other priormalignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
• •14. Ability to understand and the willingness to sign a written informed consent document in English or a Spanish consent "short form". If language other than English or Spanish, then interpreter will be used to sign English consent form.
• •15. Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE)