Actively Recruiting
Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
Led by Emory University · Updated on 2026-02-12
15
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Stage IV non-small cell lung cancer (NSCLC) based on the 8th edition AJCC staging system, including adenocarcinoma and squamous cell carcinoma.
- Measurable disease according to RECIST 1.1 criteria.
- No prior therapy for advanced NSCLC.
- Patients with brain metastases are eligible if asymptomatic or treated and stable.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Life expectancy greater than 12 weeks.
- Adequate organ and marrow function with specified blood counts and liver and kidney function.
- Tumor PD-L1 expression of 1% or higher, or unknown PD-L1 status (patients with 0% PD-L1 excluded).
- Agreement to use effective contraception or abstain from heterosexual intercourse during treatment and for 5 months after.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Prior chemotherapy or immunotherapy for advanced lung cancer.
- Previous treatment with anti-PD-1 or anti-PD-L1 therapies.
- Presence of targetable driver mutations (e.g., ALK, EGFR exon 19 deletion).
- History of allogeneic bone marrow or solid organ transplant.
- Major surgery within 28 days prior to treatment start.
- Evidence of visceral crisis due to rapid cancer progression.
- Active cancer requiring therapy other than NSCLC.
- Use of systemic immunosuppressive medications within 2 weeks prior to treatment start, except for certain allowed medications.
- History or risk of autoimmune diseases, with some controlled exceptions.
- History of certain lung diseases or active pneumonitis.
- QTc interval over 470 milliseconds.
- Known significant liver disease including viral hepatitis.
- Known HIV infection.
- Active tuberculosis.
- Live attenuated influenza vaccine within 4 weeks before treatment or during study.
- Severe infections requiring hospitalization within 4 weeks before treatment.
- Use of investigational agents within 4 weeks before treatment.
- History of severe allergic reactions to antibodies or fusion proteins.
- Pregnancy or breastfeeding, or intending to become pregnant during the study, with required negative pregnancy test for women of childbearing potential.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
S
Suresh S. Ramalingam, MD, FACP, FASCO
CONTACT
R
Ralph Millett, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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