NSCLCHYPOGRYPHENCT05703269

Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy

A study testing single fraction stereotactic radiosurgery (SSRS) and fractionated stereotactic radiosurgery (FSRS) in people with NSCLC and Renal Cell Carcinoma, run by Wake Forest University Health Sciences at 34 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC, Renal Cell Carcinoma, Breast Carcinoma
What is being tested?: single fraction stereotactic radiosurgery (SSRS) and fractionated stereotactic radiosurgery (FSRS)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 34 sitesUnited States
Study dates: 11 Jul 2023to 31 Mar 2028
Phase: Interventional
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

At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume.
Patients at initial diagnosis of brain metastases and patients with known brain metastasis treated with systemic therapy alone are eligible.
Patients who have previously undergone SRS for brain metastases are eligible if all MRIs and DICOM-RT files from prior SRS courses are available for upload to TRIAD and there are no lesions requiring re-irradiation. Prior SRS data upload is NOT required prior to enrollment and randomization. Both SSRS and FSRS are acceptable.
Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast-enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g., xyz/2). Alternatively, direct volumetric measurements via slice-by-slice contouring on a treatment planning software package can be used to calculate the total tumor volume.
Any extent of non-CNS disease is allowed. There is no requirement for non-CNS disease to be controlled prior to study entry.
For patients considered to be borderline or potentially eligible by size or volume criteria, sites have the option to send in DICOM films for central review screening.

Show all 18Show fewer

Age ≥ 18 years at the time of enrollment.
Total number of brain metastases (including resection cavities) ≤ 15 on diagnostic MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating radiation oncologist. Treatment must take place at a facility credentialed by the Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and FSRS as treatment options.
Total gross tumor volume must be ≤ 30 cc. Lesion volume will be approximated by measuring each lesion's three perpendicular diameters on contrast-enhanced T1 MRI and the product of those diameters will be divided by 2 (V = xyz/2). Direct volumetric measurements by contouring all lesions on all visible slices on treatment planning software is also acceptable. If there is a cavity, only gross residual disease within or adjacent to the cavity is counted toward the 30 cc total volume.
Ability to tolerate MRI brain with gadolinium-based contrast.
Pathologically confirmed melanoma, renal cell carcinoma, non-small cell lung cancer, small cell lung cancer, or breast cancer.
Has received, is currently receiving, or is planned to receive immune checkpoint inhibitor therapy (defined as agent targeted to PD-1/PD-L1 axis) within 30 days of the planned first day of SSRS/FSRS. Dual ICI therapy with PD-1/PD-L1 and CTLA-4 targeted agents are allowed, but patients treated with a single agent CTLA-4 targeted agent only are ineligible.
o It is not mandatory to wait for the results of next generation sequencing (NGS) or other molecular tumor testing to determine if the patient is planned to receive ICI if the enrolling physician feels that identification of a mutation that would preclude ICI therapy (such as an EGFR mutation in a patient with NSCLC) is unlikely to be identified.
Karnofsky Performance Status (KPS) ≥ 50. Refer to Appendix A.
Negative serum or urine pregnancy test within 14 days of randomization for women of child-bearing potential.
Ability to understand and the willingness to sign written informed consent.
Patients must be able to provide informed consent.
Must be able to speak, read and understand English or Spanish

Who cannot join

Prior fractionated, whole, or partial brain radiation therapy. Prior fractionated SRS is acceptable.
Prior courses of SRS for benign tumors such as meningiomas, pituitary adenomas, schwannomas may be acceptable if the treatment is > 2cm away from the site of a metastatic lesion that would be treated on this study. The study PI or a designated co-PI must review this type of case to confirm eligibility prior to enrollment.
Prior diagnosis ARE, including pseudoprogression or radiation necrosis/radionecrosis, or previously treated lesions being actively evaluated for possible ARE or local failure such as concerning imaging findings currently being tracked with short interval MRI.
Leptomeningeal carcinomatosis established by lumbar puncture cytology, or MRI imaging. In the absence of a clinical indication, a lumbar puncture is not required to confirm eligibility.
A brain metastasis that is 5 mm or less from the optic chiasm or optic nerves
Inability to tolerate brain MRI or receive gadolinium-based contrast
Planned or prior therapy with bevacizumab (or bevacizumab biosimilar) within 30 days of the planned first day of SRS as part of a systemic therapy regimen at study enrollment.
Serious intercurrent illness or medical condition judged by the local investigator to compromise the patient's safety, preclude safe administration of the planned protocol treatment, or would not permit the patient to be managed according to the protocol guidelines.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
Lovelace Radiation Oncology
Albuquerque, New Mexico, 87109
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Aspirus Langlade Hospital
Antigo, Wisconsin, 54409
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Decatur Memorial Hospital
Decatur, Illinois, 62526
Crossroads Cancer Center
Effingham, Illinois, 62401
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Francis Hospital
Greenville, South Carolina, 29601
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Mercy Hospital Springfield
Springfield, Missouri, 65804
Mercy Hospital South
St Louis, Missouri, 63128
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197

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About this study

Official title: Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on Immunotherapy (HYPOGRYPHE)

This study is designed to see if we can lower the chance of side effects from radiation in patients with breast, kidney, small cell lung cancer, non-small cell lung cancer or melanoma that has spread to the brain and who are also being treated with immunotherapy, specifically immune checkpoint inhibitor (ICI) therapy. This study will compare the usual care treatment of single fraction stereotactic radiosurgery (SSRS) given on one day versus fractionated stereotactic radiosurgery (FSRS), which is a lower dose of radiation given over a few days to determine if FSRS is better or worse at reducing side effects than usual care treatment.

Read the detailed description

This study is an open-label, randomized, Phase III trial designed to ascertain whether fractionated stereotactic radiosurgery (FSRS) results in lower incidence of Grade 2 or higher adverse radiation effect (ARE) by 9 months compared to single fraction stereotactic radiosurgery (SSRS) in patients with large brain metastases who have received or will receive immune checkpoint inhibitor (ICI) targeted to the PD-1/PD-L1 axis within 30 days of stereotactic radiosurgery (SRS). Participants will be randomized 1:1 to either SSRS or FSRS, using a minimization randomization strategy considering 5 prognostic factors of interest: radiosurgery platform (gamma knife vs. LINAC), timing of immunotherapy relative to radiation (ICI within 30 days prior to Day 1 of SRS or not), surgical status (any resection cavity vs intact metastases only), predominant tumor type (Melanoma vs. all others), and prior courses of SRS for brain metastases (yes vs. no).

Conditions: NSCLC, Renal Cell Carcinoma, Breast Carcinoma, Melanoma, Brain Metastases, Adult, Non-small Cell Lung Cancer
Being tested: single fraction stereotactic radiosurgery (SSRS), fractionated stereotactic radiosurgery (FSRS)
Keywords: Gamma Knife, Linear Accelerator, Immune Checkpoint Inhibitor (ICI) therapy, Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiosurgery (FSRS), Stereotactic Radiosurgery (SSRS)
Medical subject headings: Carcinoma, Renal Cell, Breast Neoplasms, Melanoma, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

single fraction stereotactic radiosurgery (SSRS)Radiation
SSRS is an advanced radiation technique that delivers high dose precision radiation in a single dose to discrete intracranial lesions.
fractionated stereotactic radiosurgery (FSRS)Radiation
FSRS is an advanced radiation technique that uses a lower dose precision radiation delivered over 3 to 5 treatments given daily or every other day to intracranial lesions.

Study groups in NCT05703269
Study group	Role	What they receive
SSRS = single fraction stereotactic radiosurgery	Active comparator	SSRS is an advanced radiation technique that delivers high dose precision radiation in a single dose to discrete intracranial lesions. SSRS has recently become a standard-of-care treatment for patients with 1-4 brain metastases and is also commonly used for patients with up to 15 metastases, due to improved neurocognitive outcomes compared to whole brain radiotherapy. Receives: Radiation: single fraction stereotactic radiosurgery (SSRS)
FSRS = fractionated stereotactic radiosurgery	Experimental	FSRS is an advanced radiation technique that uses a lower dose precision radiation delivered over 3 to 5 treatments given daily or every other day to intracranial lesions. Receives: Radiation: fractionated stereotactic radiosurgery (FSRS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of a Grade 2 or higher Adverse Radiation Effect (ARE)
To compare the proportion of participants experiencing Grade 2 or higher Adverse Radiation Effects (ARE) within 9 months following randomization to single fraction stereotactic radiosurgery (SSRS) vs fractionated stereotactic radiosurgery (FSRS) in patients with brain metastases ≥ 2 cm in diameter or ≥ 4cc in volume treated with concurrent immune checkpoint inhibitor (ICI) therapy.
Measured: 9 months

Secondary outcomes (4)

Compare time to composite end point
To compare the time to the composite endpoint of either local failure of a metastasis treated with SRS (as defined in Section 8.2) or first Grade 2 or higher ARE between SSRS and FSRS groups.
Measured: 9 months
Compare time to local failure between SSRS and FSRS groups
To compare time to local failure between SSRS and FSRS groups.
Measured: 9 months
Compare time to neurologic death between groups
To compare time to neurologic death between groups.
Measured: 9 months
Compare patient-reported brain tumor specific symptom burden
To compare patient-reported brain tumor specific symptom burden using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) between SRSS or FSRS groups at 9 months.
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 202331 Mar 2028

First posted30 Jan 2023
Study start11 Jul 2023
Primary completion31 Mar 2028 (estimated)
Study completion31 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLCStudies 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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Model description: Participants will be randomized 1:1 to either SSRS or FSRS, using minimization randomization strategy considering 5 prognostic factors of interest: radiosurgery platform (GK vs. LINAC), timing of immunotherapy relative to radiation (ICI within 30 days of Day 1 prior to SRS or not), surgical status (any resection cavity vs. intact metastases only), predominant tumor type (Melanoma vs. all others), and prior courses of SRS for brain metastases (yes vs. no). All baseline patient-reported outcomes and neurocognitive assessments will be collected prior to randomization to minimize bias.
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05703269
Sponsor's protocol ID: IRB00092505
Other IDs: 5UG1CA189824-08, NCI-2022-10836, WF-2201
Acronym: HYPOGRYPHE
Status last verified: Apr 2026
First submitted: 18 Jan 2023
Last updated: 6 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/ notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on Immunotherapy (HYPOGRYPHE)
ClinicalTrials.gov ID: NCT05703269
Acronym / sponsor ID: HYPOGRYPHE / IRB00092505
Conditions: NSCLC, Renal Cell Carcinoma, Breast Carcinoma, Melanoma, Brain Metastases, Adult, Non-small Cell Lung Cancer
Keywords: Gamma Knife, Linear Accelerator, Immune Checkpoint Inhibitor (ICI) therapy, Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiosurgery (FSRS), Stereotactic Radiosurgery (SSRS)
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 58 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 11 Jul 2023 (actual)
Primary completion: 31 Mar 2028 (estimated)
Study completion: 31 Mar 2028 (estimated)
First posted: 30 Jan 2023 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomized 1:1 to either SSRS or FSRS, using minimization randomization strategy considering 5 prognostic factors of interest: radiosurgery platform (GK vs. LINAC), timing of immunotherapy relative to radiation (ICI within 30 days of Day 1 prior to SRS or not), surgical status (any resection cavity vs. intact metastases only), predominant tumor type (Melanoma vs. all others), and prior courses of SRS for brain metastases (yes vs. no). All baseline patient-reported outcomes and neurocognitive assessments will be collected prior to randomization to minimize bias.

Arm	Type	Receives
SSRS = single fraction stereotactic radiosurgery	Active comparator	Radiation: single fraction stereotactic radiosurgery (SSRS)SSRS is an advanced radiation technique that delivers high dose precision radiation in a single dose to discrete intracranial lesions. SSRS has recently become a standard-of-care treatment for patients with 1-4 brain metastases and is also commonly used for patients with up to 15 metastases, due to improved neurocognitive outcomes compared to whole brain radiotherapy.
FSRS = fractionated stereotactic radiosurgery	Experimental	Radiation: fractionated stereotactic radiosurgery (FSRS)FSRS is an advanced radiation technique that uses a lower dose precision radiation delivered over 3 to 5 treatments given daily or every other day to intracranial lesions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume.
Age ≥ 18 years at the time of enrollment.
Total number of brain metastases (including resection cavities) ≤ 15 on diagnostic MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating radiation oncologist. Treatment must take place at a facility credentialed by the Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and FSRS as treatment options.
Total gross tumor volume must be ≤ 30 cc. Lesion volume will be approximated by measuring each lesion's three perpendicular diameters on contrast-enhanced T1 MRI and the product of those diameters will be divided by 2 (V = xyz/2). Direct volumetric measurements by contouring all lesions on all visible slices on treatment planning software is also acceptable. If there is a cavity, only gross residual disease within or adjacent to the cavity is counted toward the 30 cc total volume.
Ability to tolerate MRI brain with gadolinium-based contrast.

Key exclusion criteria (8 listed)

Prior fractionated, whole, or partial brain radiation therapy. Prior fractionated SRS is acceptable.
Prior courses of SRS for benign tumors such as meningiomas, pituitary adenomas, schwannomas may be acceptable if the treatment is > 2cm away from the site of a metastatic lesion that would be treated on this study. The study PI or a designated co-PI must review this type of case to confirm eligibility prior to enrollment.
Prior diagnosis ARE, including pseudoprogression or radiation necrosis/radionecrosis, or previously treated lesions being actively evaluated for possible ARE or local failure such as concerning imaging findings currently being tracked with short interval MRI.
Leptomeningeal carcinomatosis established by lumbar puncture cytology, or MRI imaging. In the absence of a clinical indication, a lumbar puncture is not required to confirm eligibility.
A brain metastasis that is 5 mm or less from the optic chiasm or optic nerves

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
single fraction stereotactic radiosurgery (SSRS)SSRS is an advanced radiation technique that delivers high dose precision radiation in a single dose to discrete intracranial lesions.	Radiation	SSRS = single fraction stereotactic radiosurgery
fractionated stereotactic radiosurgery (FSRS)FSRS is an advanced radiation technique that uses a lower dose precision radiation delivered over 3 to 5 treatments given daily or every other day to intracranial lesions.	Radiation	FSRS = fractionated stereotactic radiosurgery

Primary outcome

Occurrence of a Grade 2 or higher Adverse Radiation Effect (ARE)
Time frame: 9 months
To compare the proportion of participants experiencing Grade 2 or higher Adverse Radiation Effects (ARE) within 9 months following randomization to single fraction stereotactic radiosurgery (SSRS) vs fractionated stereotactic radiosurgery (FSRS) in patients with brain metastases ≥ 2 cm in diameter or ≥ 4cc in volume treated with concurrent immune checkpoint inhibitor (ICI) therapy.

4 secondary outcomes

Compare time to composite end point
Time frame: 9 months
Compare time to local failure between SSRS and FSRS groups
Time frame: 9 months
Compare time to neurologic death between groups
Time frame: 9 months
Compare patient-reported brain tumor specific symptom burden
Time frame: 9 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 6 Apr 2026.
Individual participant dataSharing planned: Yes. Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/ notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

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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. This study is not recruiting at the moment.

Glenn Lesser, MD study chair

Wake Forest University Health Sciences

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of a Grade 2 or higher Adverse Radiation Effect (ARE) (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703269.

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 6 Apr 2026.