Nab-paclitaxel as Second Line Treatment in Treating Older Patients with Stage IV Non-small Cell Lung Cancer

Inclusion Criteria

• Signed, written informed consent
• Diagnosis of non-small cell lung cancer (NSCLC), histologically or cytologically confirmed
• International Association for the Study of Lung Cancer (IASLC) version 7, stage IV disease; or recurrence after prior surgery or radiotherapy
• Progression following a single line of prior cytotoxic therapy including a platinum agent plus a standard cytotoxic partner other than a taxane (typically pemetrexed, gemcitabine or vinorelbine): * Previous treatment with targeted therapy will not count as a prior line of therapy if the patient’s tumor has the relevant molecular change (e.g., epidermal growth factor receptor [EGFR] mutation for erlotinib and echinoderm microtubule associated protein like 4 [EML4]/anaplastic lymphoma receptor tyrosine kinase [ALK] or receptor tyrosine kinase [ROS1] for crizotinib) * Previous treatment with immune-oncologic agents (such as nivolumab) will not count as a prior line of therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
• Hemoglobin >= 9 g/dL (it is acceptable to reach this through transfusion)
• Platelets > 100,000 cells/mm^3
• Creatinine =< 1.5 mg/dL
• Total bilirubin =< 1.5 mg/dL
• Alkaline phosphatase =< 2.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
• Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x ULN
• Recovered from all reversible toxicities related to their previous treatment (other than alopecia) to =< grade 1 or baseline
• Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
• Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment; adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
• Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
• Patients with brain metastases may participate if they have undergone appropriate treatment for the lesion(s), are at least two weeks post treatment without evidence for post-treatment progression, have no significant neurologic symptoms, and no longer require steroids for the reason of brain metastases; patients with symptoms suggestive of central nervous system (CNS) metastases should be evaluated with imaging prior to study participation

Exclusion Criteria

• Prior taxane therapy for any indication
• Less than 3 weeks elapsed since prior exposure to chemotherapy
• Pre-existing neuropathy greater than grade 1
• Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion
• Concomitant anticancer therapy, immunotherapy, or radiation therapy (no radiation within prior 2 weeks)
• Have received treatment within the last 30 days prior to study entry with any drug that has not received regulatory approval for an indication at the time of study entry
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded; breastfeeding should be discontinued prior to participation of the mother on study
• Known hypersensitivity to protein bound paclitaxel
• Any other concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol