Ascorbate With Durvalumab in Non-Small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

Official title: Assessing the Immunomodulatory Effects of Pharmacologic Ascorbate With Durvalumab (MEDI 4736) in Non-Small Cell Lung Cancer: A Window of Opportunity Trial

Status Recruiting

Clinical Trial Summary

This is a descriptive, proof of concept, open-label, randomized, 3-arm, window of opportunity trial to evaluate the immunomodulatory role of pharmacological ascorbate with Durvalumab

Clinical Trial Description

Participants in this research study have stage I Non-Small Cell Lung Cancer (NSCLC) that was found to be suitable for surgery as a first line treatment.

The usual treatment for this disease is to remove the tumor with surgery, and then evaluate after surgery if other additional treatments such as chemotherapy or targeted therapy are needed.

The purpose of this research study is to compare three different ways of treating stage 1 NSCLC, to see if adding treatment before surgery can reduce the chance of the tumor recurring after surgical removal.

In this study, patients will be randomly assigned to one of three treatments:

• Durvalumab followed by surgical resection of the tumor.

• Durvalumab plus ascorbate (also known as vitamin C), followed by surgical resection of the tumor.

• Surgical resection alone. No therapy prior to surgery. This is the same as standard care (SOC) for this disease. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT06083454
• Study type: Interventional
• Source: University of Iowa
• Contact: Muhammad Furqan, MD
• Phone: 319-356-1527
• Email: muhammad-furqan@uiowa.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: October 23, 2023
• Completion date: October 2027