RecruitingPhase 2NCT05589818

Pembrolizumab for Advanced NSCLC and PS 2-3

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


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

45 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing pembrolizumab (an immunotherapy drug) in people with advanced non-small cell lung cancer (NSCLC) who are in poor general health (performance status 2–3), a group typically excluded from clinical trials. Researchers want to know if this treatment is safe and effective even for patients who are more frail. **You may be eligible if...** - You are 18 years or older with advanced or metastatic non-small cell lung cancer - You have not received any prior systemic treatment for metastatic disease - You have never received a PD-1 or PD-L1 immunotherapy drug - You have a performance status of 2 or 3 (meaning cancer significantly affects daily activities) - Your cancer does not have an actionable genetic mutation (like EGFR, ALK, ROS1, etc.) for which there is a targeted drug **You may NOT be eligible if...** - You have an autoimmune condition requiring significant steroid use - You are currently receiving other experimental treatments - You have uncontrolled infections, heart failure, or severe psychiatric illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Mount Sinai Hospital

New York, New York, United States

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NCT05589818


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