This single center open-label trial will enroll a single cohort of patients with advanced
non-small cell lung cancer (NSCLC) who are ineligible for treatment with curative intent due
to 1) disease stage IV, or 2) inability to tolerate intensive surgery or chemo-radiation.
Patients will be eligible for the trial if ISMMS reviewed samples from tumor biopsy have a
PDL-1 TPS ≥ 1% and have ECOG performance status rated 2 or 3. All patients will receive anti
PD-1 therapy with pembrolizumab 200mg IV every 3 weeks, during which patients will also
undergo serial QOL assessments.
This trial will follow a phase II single arm, open label design. The study will enroll 45
patients evaluable for the primary endpoint of which will be change in QOL as measured by the
EORTC's QLQ-C30 between Day 1 and Day 84 +/- 7 days. Secondary outcomes including evaluation
for development of confounding mental health conditions will be evaluated via serial HADS
assessments. Concomitant radiographic assessment with PET/CT, regardless of the doses of
pembrolizumab received, will allow for evaluation of secondary efficacy outcomes, including
disease response by RECIST 1.1 criteria.