A Phase II Study of the Effects of Pembrolizumab on Quality of Life for Patients With Treatment-Naïve, Advanced or Metastatic NSCLC and Poor Performance Status
Icahn School of Medicine at Mount Sinai
Summary
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.
Description
Primary Objective To assess the effects of first-line pembrolizumab upon patient quality of life in patients with metastatic non-small cell lung cancer who are ineligible for standard first line treatments due to poor performance status (ECOG PS of 2 or 3). Secondary Objectives * To assess the clinical outcomes of first-line pembrolizumab in this patient population. * To evaluate the toxicity of first-line pembrolizumab in this patient population. * To assess patient reported QOL in the emotional domain (using HADS). * To assess baseline patient-reported performance status and correlate with…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 must not have received any PD-1 or PD-L1 inhibitor * ECOG performance status of 2 or 3 at the time of consent and on the first day of therapy * Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists. * Patients…
Interventions
- DrugPembrolizumab
Patients will be treated with the standard dose of pembrolizumab for the first 12 weeks of the study. After week 12 assessments, patients without objective progression of disease are eligible to transition to Q6W dosing of pembrolizumab 400mg IV. Patients will be offered this schedule, also an FDA-approved option, at the discretion of the treating physician, based on tolerability of the q3week regimen and clinician assessment of need for closer follow up intervals. Pembrolizumab will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Location
- Mount Sinai HospitalNew York, New York