Lung Cancer (NSCLC)Phase 2INSPIRENCT07679607
GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung
A Phase 2 study testing SOC Radiation Treatment Planning and INSPIRE Radiation Treatment Planning in people with Lung Cancer (NSCLC) and Radiation, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Radiation
- What is being tested?
- SOC Radiation Treatment Planning and INSPIRE Radiation Treatment Planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Step 1- Inclusion Criteria
- 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
- Step 2- Inclusion Criteria 1. Patient has completed 4DCT and BHCT with subsequent plans created and Radiation Oncologist has determined that patient would benefit from INSPIRE RT.
Who cannot join
- Step 1- Exclusion Criteria
- 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
- Step 2- Exclusion Criteria
- 1. Patient found to not benefit from INSPIRE RT after comparison of treatment plans.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Caitlin Eggleston, MPH, 410-369-5351, caitlineggleston@umm.edu
About this study
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
- Being tested
- SOC Radiation Treatment Planning, INSPIRE Radiation Treatment Planning
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC Radiation Treatment PlanningRadiation
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
INSPIRE Radiation Treatment PlanningRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- SOC Radiation Plan | Active comparator | Standard RT Plan Creation Receives: 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. Receives: Radiation: INSPIRE Radiation Treatment Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Number of patients with Grade 2 or higher toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v5
Local-regional control, radiographically-assessed change in radiation pneumonitis/lung fibrosis, Grade ≥ 2 toxicity per CTCAE definition.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Sawant, University of Maryland, Baltimore
- Investigators
- Amit Sawant, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679607
- Sponsor's protocol ID
- HP-00114566
- Acronym
- INSPIRE
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung
- ClinicalTrials.gov ID
- NCT07679607
- Acronym / sponsor ID
- INSPIRE / HP-00114566
- Conditions
- Lung Cancer (NSCLC), Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- SOC Radiation Plan | Active comparator | Radiation: SOC Radiation Treatment PlanningStandard RT Plan Creation |
| Arm 2- INSPIRE Radiation Plan | Experimental | Radiation: INSPIRE Radiation Treatment PlanningINSPIRE plan achieves the additional goal of sparing functional units by better modulating the low dose and the intermediate dose compared to the SOC plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Step 1- Inclusion Criteria
- Step 2- Inclusion Criteria 1. Patient has completed 4DCT and BHCT with subsequent plans created and Radiation Oncologist has determined that patient would benefit from INSPIRE RT.
Key exclusion criteria (8 listed)
- Step 1- Exclusion Criteria
- Step 2- Exclusion Criteria
- 1. Patient found to not benefit from INSPIRE RT after comparison of treatment plans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOC Radiation Treatment PlanningTwo 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 | Radiation | Arm 1- SOC Radiation Plan |
| INSPIRE Radiation Treatment PlanningTwo 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 | Radiation | Arm 2- INSPIRE Radiation Plan |
Primary outcome
Measurement of Post-Radiation retention of ventilation at 12 months through imaging.
Time frame: 12 months
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
1 secondary outcome
Number of patients with Grade 2 or higher toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Sawant, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOC Radiation Treatment Planning and INSPIRE Radiation Treatment Planning in people with Lung Cancer (NSCLC) and Radiation, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Sawant, PhD (410-328-6080, asawant@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Post-Radiation retention of ventilation at 12 months through imaging. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.