NCT05493566

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)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Given SC
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-01-07
• Completion: 2028-01-07
• First posted: 2022-08-09
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study