NCT03818776

Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody immunotherapy for lung cancer. Participants will receive 1500mg durvalumab via intravenous (IV) infusion Q4W for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48 unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. (N.b. If a participant's weight falls to 30kg (≤30 kg)), then the participant should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W after consultation between Investigator and Study Physician, until the weight improves to above 30 kg \>30 kg, at which point the participant should start receiving the fixed dosing of durvalumab 1500 mg Q4W).
RADIATION	Proton beam therapy RT	Proton beam therapy is a type of RT where the proton stops at a specific depth according to its energy which 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.

Timeline

• Start date: 2019-08-30
• Primary completion: 2022-01-27
• Completion: 2022-01-27
• First posted: 2019-01-28
• Last updated: 2024-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study