Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title: A Pilot Trial of Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable Non-Small Cell Lung Cancer With Extended Durvalumab Therapy (PARTICLE-D)

Status Terminated

Clinical Trial Summary

The purpose of this study is to treat participants with the combination of durvalumab (the study drug) and proton beam therapy. Proton beam therapy is a type of radiotherapy (RT) with a unique characteristic where the proton stops at a specific depth according to its energy. This may be advantageous in treating lung cancer because it allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.

Clinical Trial Description

All study participants will receive the same study intervention, which will consist of proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will be delivered using cardiac sparing accelerated fractionated proton radiation. Radiation will have two dose escalation schemes followed by an expansion cohort for a total of approximately 24 participants enrolled at University Hospitals Cleveland Medical Center. The objectives of this study are to evaluate the safety and feasibility of combination of durvalumab with two different schemes for accelerated fractionation proton radiation in participants who are unable to tolerate concurrent chemoradiation therapy. This will also include the evaluation of adverse events resulting from these treatment schemes. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03818776
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Terminated
• Phase: Early Phase 1
• Start date: August 30, 2019
• Completion date: January 27, 2022