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Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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)

NCT05493566•Emory University

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVE: I. To assess phenotypic, transcriptional, and epigenetic profiles of PD-1+ CD8 T cells response in patients with stage IV non-small cell lung cancer (NSCLC) treated with the combination of IL-2 and pembrolizumab. SECONDARY OBJECTIVE: I. To evaluate anti-tumor activity of the combination of IL-2 and pembrolizumab by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). II. To evaluate the safety of the combination of IL-2 and pembrolizumab. OUTLINE: Patients will be treated with pembrolizumab 200 mg IV once every 3 weeks in combination with IL-2 given at 5 million IU subcutaneously twice daily for 3 weeks (5 days on, 2 days off each week, first dose in clinic and subsequent doses at home). IL-2 will be given only for the three weeks, after which pembrolizumab will be continued as monotherapy at either 200 mg every 3 weeks or 400 mg every 6 weeks. After completion of the study treatment, patients are followed for up for 6 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have Stage IV non-small cell lung cancer (NSCLC), based on the 8th edition of the American Joint Committee on Cancer (AJCC) NSCLC Staging System. This includes adenocarcinoma and squamous cell carcinoma.
•2. Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
•3. No prior therapy for advanced NSCLC.
•5. Age greater than or equal to 18 years.
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•7. Life expectancy of greater than 12 weeks.
•8. Patients must have adequate organ and marrow function, including:
•1. Absolute neutrophil count (ANC) ≥ 1,500/mcL
•2. Platelet count ≥ 100,000/mcL
•3. Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this)
+8 more criteria

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•12. Any prior chemotherapy or immunotherapy for advanced lung cancer.
•13. Prior treatment with anti-PD-1 or anti-PD-L1 therapies or pathway-targeting agents.
•14. Any targetable driver mutation (e.g. ALK, EGFR exon 19 del, etc).
•15. Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
•16. Major surgical procedure within 28 days prior to cycle 1, day 1.
•17. Evidence of visceral crisis (severe organ dysfunction as assessed by signs, symptoms, and laboratory values, resulting from rapid progression of neoplastic disease).
•18. Active concomitant malignancy that requires therapy.
•19. Treatment with systemic immunosuppressive medications (e.g., prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Cycle 1, Day 1.
•1. Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or premedication for contrast dye allergy) are eligible.
+19 more criteria

Locations (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Key Dates

Start Date

November 1, 2022

Primary Completion Date

January 7, 2027

Completion Date

January 7, 2028

Last Updated

February 12, 2026

Enrollment

ESTIMATED participants

Conditions

Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8

Interventions

Aldesleukin

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Contacts

Suresh S. Ramalingam, MD, FACP, FASCO

CONTACT

404-778-5378 ssramal@emory.edu

Ralph Millett, MD

CONTACT

rmillet@emory.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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