Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Inclusion Criteria:

• Patients must have a cytological or histological diagnosis of non-small cell lungcancer that is metastatic or unresectable for which standard curative measures donot exist.

• No prior systemic treatment with either chemotherapy or immunotherapy fornon-curative intent. Patients may have previously received cancer treatment withcurative intent for prior early-stage disease.

• At least 18 years old.

• ECOG performance status of 0-2, as determined by the treating physician in theconsult note.

• Life expectancy of greater than 3 months.

• Patients must have normal organ and marrow function as defined below:

• absolute neutrophil count ≥1,000/mcL

• platelets ≥100,000/mcL

• Chemotherapy agents are known to be teratogenic, therefore women of child-bearingpotential and men must agree to use adequate contraception (hormonal or barriermethod of birth control) prior to study entry and for the duration of studyparticipation. Should a woman become pregnant or suspect she is pregnant whileparticipating in this study, she should inform her treating physician immediately.

• Ability to understand and the willingness to sign an IRB-approved informed consentdocument.

Exclusion Criteria:

• Nonsmall cell lung cancer that is known at registration to be positive for a tumoractivating alteration for which first line targeted therapy is indicated9;specifically, a targetable mutation in epidermal growth factor receptor (EGFR), generearrangement of anaplastic lymphoma kinase (ALK), gene rearrangement of c-rosoncogene 1 (ROS1), or mutation in B isoform of rapidly accelerated fibrosarcoma (B-Raf). For non-squamous subtypes, molecular testing of tumor and peripheral bloodshould be attempted for actionable biomarkers, but if there is an insufficientquantity of tumor material for testing and it is not feasible to attempt additionalbiopsies before starting systemic therapy, then these biomarker results are notnecessary for inclusion on the study. For squamous subtype, molecular testing shouldbe considered but is not necessary for inclusion on the study.

• Known to have an active autoimmune disease that required systemic treatment in thepast 2 years (i.e., with use of disease modifying agents, systemic corticosteroids,or immunosuppressive drugs).

• History of (non-infectious) pneumonitis that required systemic corticosteroids.

• Uncontrolled intercurrent illness including, but not limited to ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

• Pregnant women are excluded from this study because of the potential for teratogenicor abortifacient effects with chemotherapy. Because there is an unknown butpotential risk for adverse events in nursing infants secondary to treatment of themother with chemotherapy, breastfeeding should be discontinued.