RecruitingEarly Phase 1NCT05493566

Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer

A Biomarker Study of Low-Dose IL-2 Plus Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)


Sponsor

Emory University

Enrollment

15 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immune-boosting drugs — low-dose interleukin-2 (IL-2) and pembrolizumab — as a first-line treatment for stage IV (advanced) non-small cell lung cancer (NSCLC). IL-2 helps activate immune cells, while pembrolizumab removes the brakes that cancer cells use to hide from the immune system. Researchers hope the combination is more effective than either drug alone. **You may be eligible if...** - You are 18 or older with stage IV non-small cell lung cancer (adenocarcinoma or squamous cell type) - You have had no prior treatment for advanced NSCLC - Your cancer has at least one measurable spot on scans - You are in reasonably good health (ECOG 0–2) - You have a life expectancy of at least 12 weeks - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have active, untreated autoimmune disease - You are on long-term steroid medications - You have had a prior organ or stem cell transplant - You are pregnant or breastfeeding - You have uncontrolled infections or serious heart or lung conditions 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

BIOLOGICALAldesleukin

Given SC

BIOLOGICALPembrolizumab

Given IV


Locations(1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT05493566


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