Nonsmall Cell Lung Cancer StagePhase 1STELLAR IITNCT07852247
SBRT for Ultra-Central NonSmall Cell Lung Cancer
A Phase 1 study testing SBRT in people with Nonsmall Cell Lung Cancer Stage, run by Georgetown University at 1 site in United States.
Trial summary
The goal of this clinical trial is to find out if Five-fraction CyberKnife stereotactic body radiation therapy (SBRT) with real-time Synchrony® motion tracking can treat ultra-central nonsmall cell lung cancer while reducing the amount of serious side effects from SBRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer Stage
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2033
- Phase
- Phase 1
- 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
- Patients aged 18 or older.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients with confirmed tumor location using advanced imaging to ensure accurate classification of ultra-central NSCLC.
- Ability to undergo bronchoscopy and Endobronchial ultrasound (EBUS) with adequate fiducial placement
- Histologically or cytologically confirmed clinical stage T1-T2 N0 M0 NSCLC (AJCC 9th edition), with maximum tumor diameter ≤5 cm.
- Absence of overt radiological or bronchoscopy assessed gross endobronchial invasion, invasion of the trachea, esophagus, major blood vessels, or other mediastinal structures.
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- 4D-CT (computed tomography) scans will be required to evaluate tumor motion and verification at time of simulation:
- ○ Screening for ultra-central tumor deformation between inhalation and exhalation extremities will be performed via 4D-CT to avoid inappropriate margins for significant tumor motion or deformation.
- Ultra-central tumors must include:
- o Gross Tumor Volume (GTV) or Planning Target Volume (PTV) located within 1 cm (centimeter) of the Proximal Bronchial Tree (PBT) and/or at least one of the following: (1) GTV or protocol PTV within 1 cm of the PBT; or (2) GTV within 5 mm of or abutting/overlapping the esophagus, heart/pericardium, aorta, pulmonary artery, or pulmonary vein.
- Patients are eligible to receive SBRT:
- Patients deemed suitable for SBRT based on multidisciplinary evaluation;
- Medically inoperable, decline surgery or high surgical risk as determined by a thoracic surgeon or multidisciplinary tumor board;
- No prior overlapping thoracic radiation exceeding dose constraints for critical structures;
- Adequate pulmonary function to tolerate procedure;
- A minimum of two gold fiducials will be placed in or adjacent to the tumor via bronchoscopy and will be tracked/evaluated by the treating radiation oncologist and/or physicist/dosimetrist to determine quality of fiducial placement for trial inclusion.
- Patients are eligible to receive radiation therapy:
- Candidate for CyberKnife radiosurgery using Synchrony motion management;
- 4D-CT is required to evaluate tumor motion. Patients with >1.5 cm excursion in any dimension will require a 5 mm PTV margin and remain eligible only if all mandatory Organs-at-risk (OAR) dosimetric and planning constraints can be met; otherwise, they are ineligible for protocol treatment.
- OAR constraints will be prioritized over target coverage. Patients who cannot meet mandatory airway, esophagus, great vessel, heart, spinal cord, and lung constraints are not eligible for protocol treatment.
- Female patients of childbearing potential must have a negative pregnancy test prior to treatment and agree to contraception during and for a defined period after treatment.
- Patients who can comply with follow-up visits and treatment plans.
- Patients who can provide written informed consent prior to study procedures.
Who cannot join
- Patients with evidence of nodal involvement (N1-N3) or distant metastases (M1).
- Patients with previous radiation therapy to the thorax that would result in overlap with the planned treatment field.
- Patients with tumor-associated bronchial compression, defined as visible deformation or narrowing of the trachea, mainstem bronchus, or bronchus intermedius on diagnostic CT, simulation CT, or bronchoscopy.
- Patients receiving concurrent chemotherapy, immunotherapy, or targeted therapy during SBRT.
- Patients with active connective tissue disease (e.g., lupus, scleroderma, polymyositis, rheumatoid arthritis).
- Patients with interstitial lung disease of any etiology.
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- Patients on Vascular Endothelial Growth Factor (VEGF) inhibitors.
- Patients with tumor invasion of any major airways, esophagus, or major blood vessels.
- Patients with evidence of endobronchial disease.
- Patients who fail to place fiducial markers for Synchrony tracking.
- Patients who require alternate fractionation scheduling.
- Patients who are pregnant or are breastfeeding.
- Patients who are unable to lie flat for the duration of treatment (approximately 45-60 minutes per fraction).
- Patients with psychiatric illness or social situation that would limit compliance with study requirements.
- Patients who are unable to or unwilling to give informed consent.
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
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Nicole Swanson, 202-687-9194, ns1209@georgetown.edu
Jonathan Lischalk, MD
About this study
Official title: Precision SBRT for Ultra-Central NSCLC: Evaluating Safety and Efficacy With CyberKnife Synchrony Motion Management
The goal of this clinical trial is to find out if Five-fraction CyberKnife stereotactic body radiation therapy (SBRT) with real-time Synchrony® motion tracking can treat ultra-central nonsmall cell lung cancer while reducing the amount of serious side effects from SBRT. Participants will
- receive radiation treatment every other day over two weeks using a machine called the CyberKnife®, which uses a technology called Synchrony® motion management, which tracks your tumor in real time as it moves with your breathing. This allows the radiation beam to follow your tumor during treatment, helping to deliver the radiation more accurately to the tumor while reducing the dose to nearby healthy organs.
- return for follow up visits after treatment at months 3, 6, 9, 12, 18, 24 and then every year for 5 years to be evaluated
- complete questionnaires before and after treatment.
- Conditions
- Nonsmall Cell Lung Cancer Stage
- Being tested
- SBRT
- Keywords
- Ultra-central nonsmall cell lung cancer, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
50 Grays (Gy) delivered in 5 fractions, delivered using Cyberknife with Synchrony motion tracking, every other day over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cyberknife with Synchrony Motion Tracking | Experimental | Not described Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of grade 3 or higher toxicity following SBRT with CyberKnife regimen with real-time motion tracking for ultra-central NSCLC.
The primary safety endpoint is the cumulative incidence of acute or late grade ≥3 AEs occurring within 12 months and assessed as possibly, probably, or definitely related to protocol treatment. AEs will be graded using the NCI CTCAE version 6.0. Prespecified thoracic AEs include dyspnea, cough, pneumonitis, lung infection, atelectasis, bronchial stenosis or obstruction, bronchopulmonary hemorrhage or hemoptysis, fistula, dysphagia or esophagitis, pleural or pericardial effusion, and chest pain.
Measured: Patients will be assessed for toxicity throughout treatment with radiation therapy (RT). Following RT, all participants will be evaluated through 12 months for the primary safety endpoint and will continue protocol safety follow-up through 5 years.
Secondary outcomes (12)
Local control (LC)
LC will be calculated using the cumulative incidence method and reported along with a 95% exact binomial confidence interval (CI).
Measured: Until Trial Completed (up to 5 years)
Regional nodal progression
The regional nodal progression is defined as the length of time from radiation completion of the first documented presence of enlarged lymph nodes >1 cm [short axis] in the hilum or mediastinum and biopsy confirmed. The Kaplan-Meier method will be used for the analyses, and the median regional nodal progression free time with 95% CI will be reported, respectively, if available.
Measured: Until Trial Completed (up to 5 years)
Distant metastasis-free survival (DMFS)
DMFS is defined as the length of time, from radiation completion to the first evidence of clinical distant metastatic spread of NSCLC outside of the lung cavity or death, whichever occurs first. Patients who are alive and free from clinical distant metastasis will be censored at the date of last follow-up for DMFS. The Kaplan-Meier method will be used for the analyses, and the median DMFS with 95% CI will be reported, respectively, if available.
Measured: Until trial completed (up to 5 years)
Progression-free survival (PFS)
PFS is defined as the length of time, from radiation completion to the first evidence of clinical/radiographic progression, biopsy confirmation when feasible, distant metastasis, or death, whichever comes first. Patients who are alive and free from disease progression will be censored at the date of last follow-up or date of death, whichever occurs first. SOC PET/CT imaging results will be reviewed and collected. The Kaplan-Meier method will be used for the analyses, and the median PFS with 95% CI will be reported, respectively, if available.
Measured: From baseline through the follow up period at 3, 6, 9, 12, 18, 24 months followed annually thereafter up to 5 years.
Overall survival (OS)
OS is defined as the length of time, from radiation completion, a patient lives until death. Patients who are alive will be censored at either the date of last follow-up or date of death, whichever occurs first. The Kaplan-Meier method will be used for the analyses, and the median survival time with 95% CI will be reported, respectively, if available.
Measured: Up to 5 years
Incidence of treatment related acute and late grade 2 or higher toxicity and late grade ≥3 toxicity
The incidence of treatment related acute and late grade ≥2 and late grade ≥3 AEs (AESI) will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used.
Measured: From the start of radiation treatment throught 12 months and 24 months.
Patient-Reported Quality of Life Outcomes (QoL)
Patient-reported QoL outcomes through designated questionnaires. The EORTC QoL questionnaire (QLQ)-C30 is a 30-item form for lung cancer patients that incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/ QoL scale, and several single items assessing additional symptoms commonly experienced by cancer patients. The EORTC QLQ-LC13 is a clinically validated tool to assess disease and treatment specific symptoms in lung cancer patients that will participate in clinical trials. Quality of life outcomes will be summarized over time using descriptive statistics and graphical displays. The Wilcoxon signed-rank test will be used for comparisons of QoL between follow-up time points and baseline. Repeated measure models may be employed to assess changes in QoL outcomes over time if deemed necessary.
Measured: Pre-radiation/baseline, 3, 6, 9, 12, 18, 24 months post-radiation and then annually thereafter until 5 years.
Pulmonary Function Testing - Forced Expiratory Volume in One Second (FEV1)
The pulmonary function testing changes will be evaluated including serial PFT, FEV1, FVC (forced vital capacity), DLCO and TLC (total lung capacity) to assess the impact of precision SBRT on respiratory function.
Measured: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Pulmonary Function Testing - FVC (Forced Vital Capacity)
The pulmonary function testing changes will be evaluated including serial PFT, FEV1, FVC (forced vital capacity), DLCO and TLC (total lung capacity) to assess the impact of precision SBRT on respiratory function.
Measured: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Pulmonary Function Testing - Diffusing Capacity for Carbon Monoxide (DLCO)
The pulmonary function testing changes will be evaluated including serial PFT, FEV1, FVC (forced vital capacity), DLCO and TLC (total lung capacity) to assess the impact of precision SBRT on respiratory function.
Measured: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Pulmonary Function Testing - TLC (total lung capacity)
The pulmonary function testing (PFT) changes will be evaluated including serial PFT, FEV1, FVC (forced vital capacity), DLCO and TLC (total lung capacity) to assess the impact of precision SBRT on respiratory function.
Measured: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Correlation of Dose-volume histogram (DVH) parameters for organs-at-risk (OARs) with observed toxicities and local control
DVH parameters for OARs will be analyzed with their correlation with observed toxicities and local control. Descriptive statistics will be presented for DVH parameters for organs-at-risk (OARs). Two-sided t-test or Mann-Whitney test, ANOVA or Kruskal-Wallis test will be utilized for continuous DHV parameters and Chi-square test or Fisher's exact test will be used for categorical DHV parameters to assess associations between DVH parameters and toxicity and LC, respectively.
Measured: through 12 months post-radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2031 (estimated)
- Study completionNov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung Cancer StageStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Accuray Incorporated
- Responsible party
- Sponsor
- Investigators
- Jonathan Lischalk, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852247
- Sponsor's protocol ID
- STUDY00011025
- Acronym
- STELLAR IIT
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision SBRT for Ultra-Central NSCLC: Evaluating Safety and Efficacy With CyberKnife Synchrony Motion Management
- ClinicalTrials.gov ID
- NCT07852247
- Acronym / sponsor ID
- STELLAR IIT / STUDY00011025
- Conditions
- Nonsmall Cell Lung Cancer Stage
- Keywords
- Ultra-central nonsmall cell lung cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Accuray Incorporated
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Nov 2033 (estimated)
- First posted
- 1 Oct 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.
The goal of this clinical trial is to find out if Five-fraction CyberKnife stereotactic body radiation therapy (SBRT) with real-time Synchrony® motion tracking can treat ultra-central nonsmall cell lung cancer while reducing the amount of serious side effects from SBRT. Participants will
- receive radiation treatment every other day over two weeks using a machine called the CyberKnife®, which uses a technology called Synchrony® motion management, which tracks your tumor in real time as it moves with your breathing. This allows the radiation beam to follow your tumor during treatment, helping to deliver the radiation more accurately to the tumor while reducing the dose to nearby healthy organs.
- return for follow up visits after treatment at months 3, 6, 9, 12, 18, 24 and then every year for 5 years to be evaluated
- complete questionnaires before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyberknife with Synchrony Motion Tracking | Experimental | Radiation: SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients aged 18 or older.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients with confirmed tumor location using advanced imaging to ensure accurate classification of ultra-central NSCLC.
- Ability to undergo bronchoscopy and Endobronchial ultrasound (EBUS) with adequate fiducial placement
- Histologically or cytologically confirmed clinical stage T1-T2 N0 M0 NSCLC (AJCC 9th edition), with maximum tumor diameter ≤5 cm.
Key exclusion criteria (15 listed)
- Patients with evidence of nodal involvement (N1-N3) or distant metastases (M1).
- Patients with previous radiation therapy to the thorax that would result in overlap with the planned treatment field.
- Patients with tumor-associated bronchial compression, defined as visible deformation or narrowing of the trachea, mainstem bronchus, or bronchus intermedius on diagnostic CT, simulation CT, or bronchoscopy.
- Patients receiving concurrent chemotherapy, immunotherapy, or targeted therapy during SBRT.
- Patients with active connective tissue disease (e.g., lupus, scleroderma, polymyositis, rheumatoid arthritis).
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 |
|---|---|---|
| SBRT50 Grays (Gy) delivered in 5 fractions, delivered using Cyberknife with Synchrony motion tracking, every other day over 2 weeks. | Radiation | Cyberknife with Synchrony Motion Tracking |
Primary outcome
Cumulative incidence of grade 3 or higher toxicity following SBRT with CyberKnife regimen with real-time motion tracking for ultra-central NSCLC.
Time frame: Patients will be assessed for toxicity throughout treatment with radiation therapy (RT). Following RT, all participants will be evaluated through 12 months for the primary safety endpoint and will continue protocol safety follow-up through 5 years.
The primary safety endpoint is the cumulative incidence of acute or late grade ≥3 AEs occurring within 12 months and assessed as possibly, probably, or definitely related to protocol treatment. AEs will be graded using the NCI CTCAE version 6.0. Prespecified thoracic AEs include dyspnea, cough, pneumonitis, lung infection, atelectasis, bronchial stenosis or obstruction, bronchopulmonary hemorrhage or hemoptysis, fistula, dysphagia or esophagitis, pleural or pericardial effusion, and chest pain.
12 secondary outcomes
Local control (LC)
Time frame: Until Trial Completed (up to 5 years)
Regional nodal progression
Time frame: Until Trial Completed (up to 5 years)
Distant metastasis-free survival (DMFS)
Time frame: Until trial completed (up to 5 years)
Progression-free survival (PFS)
Time frame: From baseline through the follow up period at 3, 6, 9, 12, 18, 24 months followed annually thereafter up to 5 years.
Overall survival (OS)
Time frame: Up to 5 years
Incidence of treatment related acute and late grade 2 or higher toxicity and late grade ≥3 toxicity
Time frame: From the start of radiation treatment throught 12 months and 24 months.
Patient-Reported Quality of Life Outcomes (QoL)
Time frame: Pre-radiation/baseline, 3, 6, 9, 12, 18, 24 months post-radiation and then annually thereafter until 5 years.
Pulmonary Function Testing - Forced Expiratory Volume in One Second (FEV1)
Time frame: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Pulmonary Function Testing - FVC (Forced Vital Capacity)
Time frame: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Pulmonary Function Testing - Diffusing Capacity for Carbon Monoxide (DLCO)
Time frame: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Pulmonary Function Testing - TLC (total lung capacity)
Time frame: Pre-radiation/baseline to post-radiation follow-up at 6 months, 12 months, 24 months and annually thereafter until 5 years.
Correlation of Dose-volume histogram (DVH) parameters for organs-at-risk (OARs) with observed toxicities and local control
Time frame: through 12 months post-radiation
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 Oct 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.
Jonathan Lischalk, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SBRT in people with Nonsmall Cell Lung Cancer Stage, run by Georgetown University 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 23 inclusion and 15 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 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jonathan Lischalk, MD (2026879194, Jonathan.W.Lischalk@gunet.georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of grade 3 or higher toxicity following SBRT with CyberKnife regimen with real-time motion tracking for ultra-central NSCLC. (time frame: Patients will be assessed for toxicity throughout treatment with radiation therapy (RT). Following RT, all participants will be evaluated through 12 months for the primary safety endpoint and will continue protocol safety follow-up through 5 years.). 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 Oct 2026.