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

Stage IV Lung Cancer AJCC v8 Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05493566
Study type Interventional
Source Emory University
Contact Suresh S. Ramalingam, MD, FACP, FASCO
Phone 404-778-5378
Email ssramal@emory.edu
Status Recruiting
Phase Early Phase 1
Start date November 1, 2022
Completion date January 7, 2026
View Details
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