GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung

NCT07679607 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HP-00114566
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Decreased respiratory function is a common side effect experienced by non-small cell lung cancer (NSCLC) patients who receive radiation therapy. In current clinical practice when treating cancerous lesions in the lung, it is not standard to explicitly try and avoid excessive radiation dose and therefore radiation injury to smaller airways. However, because of this patients may obtain damage to an airway segment can cause downstream regions in the lung to lose their "supply line" and, therefore, cause patients to lose the ability to exchange oxygen with the blood. The purpose of this clinical trial is to systematically compare post-treatment lung function of those who receive regular clinical radiation therapy (standard of care \[SoC\]) versus those who receive the airway-sparing radiation therapy regimen. The investigators hope to show that, by preserving airways and connected lung regions, participants will be able to retain a larger amount of their lung function, which will have a direct, positive impact on their post-treatment quality of life.

Conditions

Lung Cancer (NSCLC); Radiation

Outcome Measures

Primary Outcomes (1)

• Measurement of Post-Radiation retention of ventilation at 12 months through imaging.

  The central objective of this trial is to determine if dose-sparing of airways and connected high-functioning sub-lobar lung volumes leads to superior preservation of post-RT ventilation compared to that achieved through SOC RT

  12 months

Secondary Outcomes (1)

• Number of patients with Grade 2 or higher toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v5

  12 months

Study Arms (2)

Arm 1- SOC Radiation Plan

ACTIVE COMPARATOR

Standard RT Plan Creation

Radiation: SOC Radiation Treatment Planning

Arm 2- INSPIRE Radiation Plan

EXPERIMENTAL

INSPIRE plan achieves the additional goal of sparing functional units by better modulating the low dose and the intermediate dose compared to the SOC plan.

Radiation: INSPIRE Radiation Treatment Planning

Interventions

SOC Radiation Treatment Planning RADIATION

Two treatment plans will be created for each patient - an SOC RT plan and an INSPIRE RT plan. Both plans will fulfill clinical dosimetric objectives for tumor target and OARs, and will need to be reviewed and approved by the Radiation Oncologist. The trial will allow intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Both techniques have been validated for INSPIRE RT previously. Both plans meet clinical dosimetric objectives. The INSPIRE plan achieves the additional goal of sparing functional units by better modulating the low dose and the intermediate dose compared to the SOC plan

Arm 1- SOC Radiation Plan

INSPIRE Radiation Treatment Planning RADIATION

Two treatment plans will be created for each patient - an SOC RT plan and an INSPIRE RT plan. Both plans will fulfill clinical dosimetric objectives for tumor target and OARs, and will need to be reviewed and approved by the Radiation Oncologist. The trial will allow intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Both techniques have been validated for INSPIRE RT previously. Both plans meet clinical dosimetric objectives. The INSPIRE plan achieves the additional goal of sparing functional units by better modulating the low dose and the intermediate dose compared to the SOC plan

Arm 2- INSPIRE Radiation Plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage III NSCLC per AJCC ver 9
• Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemothrapy, immunotherapy).
• No restrictions on number radiotherapy fractions, or location/number of lesions
• ECOG performance status ≤ 3
• Ability to hold breath for ≥ 15 seconds
• Patient has signed informed consent document and agreed to study procedures

You may not qualify if:

• Prior lung cancer-directed radiotherapy
• Recent (\< 12 mo) or planned lung surgery (which would confound pre- and post-RT lung function measures)
• Patients with metal implants or metal stents in the thoracic region
• Known severe chronic obstructive pulmonary disease or interstitial lung disease
• Women who are pregnant or trying to get pregnant
• \. Patient found to not benefit from INSPIRE RT after comparison of treatment plans.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Amit Sawant, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Sawant, PhD

CONTACT

410-328-6080; asawant@som.umaryland.edu

Caitlin Eggleston, MPH

CONTACT

410-369-5351; caitlineggleston@umm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)