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NCT05589818 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab for Advanced NSCLC and PS 2-3
A Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT05589818 is a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 45 participants, below the 288-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05589818, a Phase 2 study of Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2023-05-26 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05589818
The ClinicalTrials.gov registry entry for NCT05589818 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (84% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT05589818 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05589818 about?
NCT05589818 is a clinical study titled "Pembrolizumab for Advanced NSCLC and PS 2-3". 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 f...
What is the current status of trial NCT05589818?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2023-05-26. Estimated completion is 2028-05.
What conditions does trial NCT05589818 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).
What interventions are being tested in trial NCT05589818?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT05589818?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05589818 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.