Nab-Paclitaxel with or without Carboplatin in Treating Elderly Patients with Stage IV Non-small Cell Lung Cancer

Inclusion Criteria

• Patient able and willing to comply with study procedures as per protocol, including the geriatric assessment at the time of study enrollment
• 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
• 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
• Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (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) version (v)1.1; 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
• 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 central nervous system (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
• Life expectancy of greater than 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have a comprehensive geriatric assessment and chemotherapy toxicity assessment score between 7-17
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
• Platelets > 100,000 cells/mm^3
• Total bilirubin =< 1.5 mg/dL (unless there is a known history of Gilbert's syndrome)
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [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 x upper limit of normal range if bone or liver metastases
• Creatinine clearance > 25 mL/min or creatinine =< 1.5 mg/dL
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are eligible if they have been on antiretrovirals (ARVs) for >= 6 months and undetectable viral loads
• Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
• No other prior malignancy 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
• 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
• Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])

Exclusion Criteria

• Patients who have had palliative chemotherapy prior to entering the study < 12 months from enrollment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents or have received immunotherapy
• Known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutated disease (molecular testing not required prior to study entry)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, or nab-paclitaxel
• 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
• Preexisting peripheral neuropathy of grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v 4.0)
• Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for >= 2 weeks prior to signing informed consent form; magnetic resonance imaging of the brain (or computed tomography scan w/contrast) is preferred for diagnosis