Non-small Cell Lung CancerPhase 1/2NCT04210492
Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
A Phase 1/2 study testing 45 Gray (Gy) regimen in people with Non-small Cell Lung Cancer, run by Yale University at 6 sites in United States.
Trial summary
The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- 45 Gray (Gy) regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Aug 2020to Jan 2030
- Phase
- Phase 1/2
- 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
- Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs.
- ECOG Performance Status of 0-2
- Age > 18
- Patients must sign a study-specific consent form.
Who cannot join
- Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in <3Gy per fraction):
- Spinal cord previously irradiated to > 40 Gy
- Brachial plexus previously irradiated to > 50 Gy
- Small intestine, large intestine, or stomach previously irradiated to > 45Gy
- Brainstem previously irradiated to > 50 Gy
- Lung previously irradiated with prior V20Gy > 35%
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- Active systemic, pulmonary, or pericardial infection
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Pregnant or lactating
- Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Jennifer Pope, 203-494-3732, jennifer.pope@yale.edu
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Jennifer Pope, 203-494-3732, jennifer.pope@yale.edu
- Recruiting
Smilow Cancer Hospital - Hamden Care Center
Hamden, Connecticut, 06518
Jennifer Pope, 203-494-3732, jennifer.pope@yale.edu
- Recruiting
Smilow Cancer Hospital
New Haven, Connecticut, 06511
Jennifer Pope, 203-494-3732, Jennifer.Pope@yale.edu
- Recruiting
Smilow Cancer Hospital Care Center - Trumbull
Trumbull, Connecticut, 06611
Jennifer Pope, 203-494-3732, jennifer.pope@yale.edu
- Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Jennifer Pope, 203-494-3732, jennifer.pope@yale.edu
About this study
Official title: Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.
Read the detailed description
The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results.
The outcomes of the metastatic patients will also be reported.
There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- 45 Gray (Gy) regimen
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
45 Gray (Gy) regimenRadiation
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
| Study group | Role | What they receive |
|---|---|---|
| 45 Gy | Experimental | Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions. Receives: Radiation: 45 Gray (Gy) regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the stereotactic body radiotherapy regimen (SBRT)
Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
Measured: From administration of SBRT up to 2 years post-SBRT
local control (LC) of 3-fraction stereotactic body radiotherapy
The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%.
Measured: Up to 10 years post-enrollment.
Secondary outcomes (5)
lobar control
Absence of primary tumor failure or involved lobe failure or both.
Measured: Up to 10 years post-enrollment.
regional control
Absence of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably computer tomography scans) within the lung, bronchial hilum, or the mediastinum.
Measured: Up to 10 years post-enrollment.
distant control
Measured: Up to 10 years post-enrollment.
overall survival
Measured: Up to 10 years post-enrollment.
progression-free survival
Measured: Up to 10 years post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start26 Aug 2020
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Yale 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention group will be compared with historical controls.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry S. Park, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210492
- Sponsor's protocol ID
- 2000025868
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2019
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
- ClinicalTrials.gov ID
- NCT04210492
- Acronym / sponsor ID
- 2000025868
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 24 Dec 2019 (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 purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.
Detailed description
The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results.
The outcomes of the metastatic patients will also be reported.
There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention group will be compared with historical controls.
| Arm | Type | Receives |
|---|---|---|
| 45 Gy | Experimental | Radiation: 45 Gray (Gy) regimenDeescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs.
- ECOG Performance Status of 0-2
- Age > 18
- Patients must sign a study-specific consent form.
Key exclusion criteria (10 listed)
- Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in <3Gy per fraction):
- Active systemic, pulmonary, or pericardial infection
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Pregnant or lactating
- Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
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 |
|---|---|---|
| 45 Gray (Gy) regimenDeescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions. | Radiation | 45 Gy |
Primary outcome
Safety of the stereotactic body radiotherapy regimen (SBRT)
Time frame: From administration of SBRT up to 2 years post-SBRT
Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
local control (LC) of 3-fraction stereotactic body radiotherapy
Time frame: Up to 10 years post-enrollment.
The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%.
5 secondary outcomes
lobar control
Time frame: Up to 10 years post-enrollment.
regional control
Time frame: Up to 10 years post-enrollment.
distant control
Time frame: Up to 10 years post-enrollment.
overall survival
Time frame: Up to 10 years post-enrollment.
progression-free survival
Time frame: Up to 10 years post-enrollment.
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 17 Jun 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.
Henry S. Park, MD, MPH principal investigator
Yale University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 45 Gray (Gy) regimen in people with Non-small Cell Lung Cancer, run by Yale University at 6 sites 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 combined 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.
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 Henry S. Park, MD, MPH (203-200-2100, henry.park@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the stereotactic body radiotherapy regimen (SBRT) (time frame: From administration of SBRT up to 2 years post-SBRT). The study lists 2 primary outcomes in all. 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 17 Jun 2026.