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

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT05493566
Trial Phases:		Protocol IDs:	WINSHIP5477-21 (primary) NCI-2022-00931 STUDY00003612
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05493566

Summary

This early phase I trial investigates whether low-dose interleukin-2 (IL-2) and pembrolizumab works in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. IL-2 works in the body to help create more T-cells and strengthens the immune system. Giving IL-2 and pembrolizumab may improve the response of the immune system against cancer and result in better outcomes in patients with stage IV non-small cell lung cancer.

Objectives

PRIMARY OBJECTIVE:
I. Measuring the phenotypic, transcriptional, and epigenetic profiles of PD-1+ CD8 T cells as well as tumor response in patients with stage IV non-small cell lung cancer (NSCLC) treated with the combination of aldesleukin (IL-2) and pembrolizumab.

SECONDARY OBJECTIVE:
I. Assessment of the safety profile, response rate, and overall survival.

OUTLINE:
Patients receive aldesleukin subcutaneously (SC) twice daily (BID) on days 1-5, 8-12, and 15-19 of cycle 1. Patients also receive pembrolizumab intravenously (IV) on day 1. Cycles repeat every 3 or 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of the study treatment, patients are followed for up for 6 weeks.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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