The Effect of Pembrolizumab on Quality of Life in Patients with Treatment-Naive Locally Advanced or Metastatic Non-small Cell Lung Cancer with Poor Performance Status

Inclusion Criteria

• Men and women, aged 18 years and older, with locally advanced NSCLC who are ineligible for definitive surgical resection or concurrent chemoradiation, or metastatic NSCLC
• Patients must not have received any systemic therapy for metastatic cancer
• Patients who have received any PD-1 or PD-L1 inhibitor in the neoadjuvant, adjuvant, or consolidation setting for resectable or locally advanced NSCLC must have received their last dose of the inhibitor at least 6 months prior to cycle 1 day 1 (C1D1)
• ECOG performance status of 2 or 3 as determined by the treating investigator
• Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line Food and Drug Administration (FDA) approved targeted therapy exists
• Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. May be done within 6 weeks of screening
• Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS directed therapy is not required and is unlikely to be required during the first cycle of therapy
• Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial
• Absolute neutrophil count >= 1,000/mcL
• Platelets >= 75,000/mcl
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) =< 3 x ULN or =< 5 x ULN if liver metastases present
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 3 days prior to cycle 1 day 1 (C1D1) of pembrolizumab therapy. For the purposes of this trial, WOCBP are defined as women who have had a menstrual period within the last 48 months
• Provision of signed and dated informed consent form
• Ability to take the study medication, and complete the study questionnaires
• Stated willingness to comply with all study procedures for the duration of the study
• For women of reproductive potential, agreement to use highly effective contraception during study treatment and for at least 4 months after the final dose
• For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with female partners of reproductive potential

Exclusion Criteria

• Uncontrolled autoimmune conditions
• Patients who are receiving other investigational agents
• 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
• Patients with known leptomeningeal disease for which CNS therapy is required
• Pregnant or lactating patients