Back to search results

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

This study is looking at a new combination treatment for people with Stage IV non-small cell lung cancer (NSCLC). It combines two drugs: aldesleukin (a low-dose form of interleukin-2, or IL-2) and pembrolizumab. Researchers want to see how this combination affects your immune system's T cells and if it can shrink tumors. You may be able to join if you have Stage IV NSCLC that has not been treated before and your cancer can be measured. The study is currently unclear about its recruitment status and plans to enroll 15 participants.

Study design
This is an early-phase study that will enroll 15 participants. It is an interventional study, meaning participants will receive the study treatments.
What's involved
You will receive pembrolizumab intravenously (IV) every three weeks. Aldesleukin will be given as a shot under the skin (SC) twice daily for three weeks, with some doses given at home. After three weeks, you will continue pembrolizumab alone.
Compensation
Not stated in the trial record.
Follow-up
After your study treatment is complete, you will be followed for six weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05493566

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Emory University
~15 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:AldesleukinPembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immune Response To Combination IL-2 and Pembrolizumab
Measured over Change from Baseline at weeks 1, 2, 3, 6, 12, and 18

Conditions

Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Suresh S Ramalingam, MD, FACP, FASCO · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Suresh S. Ramalingam, MD, FACP, FASCO
[email protected]
404-778-5378
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Rash must cover \< 10% of body surface area (BSA)
Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
No acute exacerbations of underlying condition within the last 12 months (requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids) 21. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. 22. QTc of \>470 msec by EKG. 23. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease. 24. Known HIV infection. 25. Active tuberculosis. 26. Administration of a live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks before Cycle 1, Day 1 or at any time during the study. 27. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 28. Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer). 29. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 30. Patients who are pregnant or lactating, or who are intending to become pregnant during the study.

What this trial measures

  • Immune Response To Combination IL-2 and PembrolizumabChange from Baseline at weeks 1, 2, 3, 6, 12, and 18

    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.