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NCT05493566 · ClinicalTrials.gov registry record · Early Phase 1
Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
A Early Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by Emory University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05493566: Recruiting Early Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by Emory University.
NCT05493566 is a Early Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 15 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05493566, a Early Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improved anti-tumor activity in response to this combination. This study will evaluate T cell function as well as clinical outcomes associated with this combination therapy.
Primary Outcome
Percentage of patients that express a greater than 1.5-fold increase in Ki-67 + PD-L1 + CD8 T cells in peripheral blood by week 3 of combination therapy. A 95% exact confidence interval will be estimated using the Clopper-Pearson method. Descriptive statistical analysis will be utilized to determine frequencies and percentages for categorical measurements.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Aldesleukin
Study Locations (1)
Georgia
- Emory University/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2028-01-07 |
| Phase | Early Phase 1 |
What NCT05493566 shows while recruiting
NCT05493566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05493566 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05493566 about?
NCT05493566 is a clinical study titled "Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer". This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improv...
What is the current status of trial NCT05493566?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2022-11-01. Estimated completion is 2028-01-07.
What conditions does trial NCT05493566 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8.
What interventions are being tested in trial NCT05493566?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Aldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT05493566?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05493566 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Lung Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05493566's enrollment target sits among peer trials
15 68th of 81 higher than 12 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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