SBRT for Ultra-Central NonSmall Cell Lung Cancer

NCT07852247 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: STUDY00011025
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Ultra-central nonsmall cell lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Until Trial Completed (up to 5 years)

• Regional nodal progression

  Until Trial Completed (up to 5 years)

• Distant metastasis-free survival (DMFS)

  Until trial completed (up to 5 years)

• Progression-free survival (PFS)

  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)

  Up to 5 years

Study Arms (1)

Cyberknife with Synchrony Motion Tracking

EXPERIMENTAL

Radiation: SBRT

Interventions

SBRT RADIATION

50 Grays (Gy) delivered in 5 fractions, delivered using Cyberknife with Synchrony motion tracking, every other day over 2 weeks.

Cyberknife with Synchrony Motion Tracking

Eligibility Criteria

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

You may qualify if:

• 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.
• D-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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Accuray Incorporated: collaborator
• Georgetown University: lead

Study Sites (1)

Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Study Officials

• Jonathan Lischalk, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Lischalk, MD

CONTACT

2026879194; Jonathan.W.Lischalk@gunet.georgetown.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2033
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)