Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
This pilot study is configured as a non-inferiority comparison of Performance Status 2
 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority
 in terms of efficacy (progression-free survival, overall survival) and safety (rates of
 adverse events, quality of life) when treating Performance Status 2 patients with the same
 first-line immunotherapy-based regimen as Performance Status 0-1 patients.
Primary Objective: To demonstrate that proportion of Performance Status 2 participants with
 progression-free survival at 12 weeks is not inferior to the corresponding proportion of
 Performance Status 0-1 patients.

 Secondary Objective(s)

 -  To demonstrate that incidence of treatment-related adverse events at 12 weeks in the
 Performance Status 2 group is not higher than that occurring in the Performance Status
 0-1 groups.

 -  To demonstrate that change in overall quality of life/global health status at 12 weeks
 is not inferior in the Performance Status 2 group compared to the change in the
 Performance Status 0-1 group.

 -  To demonstrate that proportion of participants with deterioration in lung-cancer
 specific symptoms at 12 weeks in the Performance Status 2 group is not higher than the
 corresponding proportion in the Performance Status 0-1 group.
Inclusion Criteria:

 -  Patients must have histologically confirmed NSCLC that is metastatic or unresectable
 for which standard curative measures do not exist.

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

 -  At least 18 years old.

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

 -  Life expectancy of greater than 3 months.

 -  Patients must have radiographically measurable metastatic disease by RECIST criteria.

 -  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-bearing
 potential and men must agree to use adequate contraception (hormonal or barrier method
 of birth control) prior to study entry and for the duration of study participation.
 Should a woman become pregnant or suspect she is pregnant while participating in this
 study, she should inform her treating physician immediately.

 -  Ability to understand and the willingness to sign an IRB-approved informed consent
 document.

 Exclusion Criteria:

 -  Nonsmall cell lung cancer that is known at registration to be positive for a tumor
 activating alteration for which first line targeted therapy is indicated;
 specifically, a targetable mutation in epidermal growth factor receptor (EGFR), gene
 rearrangement of anaplastic lymphoma kinase (ALK), gene rearrangement of c-ros
 oncogene 1 (ROS1), or mutation in B isoform of rapidly accelerated fibrosarcoma
 (B-Raf).

 -  Known to have an active autoimmune disease that required systemic treatment in the
 past 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 active
 infection, 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 from this study because of the potential for teratogenic
 or abortifacient effects with chemotherapy. Because there is an unknown but potential
 risk for adverse events in nursing infants secondary to treatment of the mother with
 chemotherapy, breastfeeding should be discontinued.