NSCLCPhase 2NCT06738160

The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Narlumosbart and Stereotactic Body Radiation Therapy in people with NSCLC and Stereotactic Body Radiation Therapy (SBRT), run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: NSCLC, Stereotactic Body Radiation Therapy (SBRT), Immunotherapy
What is being tested?: Narlumosbart and Stereotactic Body Radiation Therapy
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteChina
Study dates: 15 Feb 2025to 30 Dec 2028
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent prior to the implementation of any trial-related procedures;
Age 18-80 years old;
Histologically or cytologically confirmed stage IV NSCLC according to the TNM Classification of Malignant Tumours, 9th edition；
Histologically confirmed bone metastases requiring local radiotherapy；
Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);
Driver genes (EGFR, ALK, ROS-1) negative in adenocarcinoma patients (genetic testing not required for squamous cell carcinoma) ;

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At least one evaluable non-bone lesion (refer to RECIST1.1);
Bone metastases other than the lesions to be radiotherapy do not require local treatment (surgery or radiotherapy) intervention after evaluation;
ECOG score 0-1 points;
Expected survival time > 3 months;
Adequate organ function, defined as meeting all of the following laboratory criteria within 14 days prior to enrollment: 1) ANC ≥1.5×10⁹/L (no G-CSF); 2) Platelets ≥100×10⁹/L (no transfusion); 3) Haemoglobin ≥9 g/dL (no transfusion/EPO); 4) Bilirubin ≤1.5×ULN; 5) AST/ALT ≤2.5×ULN (≤5×ULN if liver metastases); 6) Creatinine ≤1.5×ULN or CrCl ≥60 mL/min; 7) INR/PT ≤1.5×ULN; 8) TSH within normal limits (or FT3/FT4 normal if TSH abnormal); 9) Cardiac enzymes (troponin I, CK-MB) ≤ ULN (isolated abnormalities not clinically significant are permitted).

Who cannot join

The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
The lesion is an isolated lesion and can be treated radically;
Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;
The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after evaluation;
Presence of active brain metastases;
Other malignancies within 5 years (except cured non-melanoma skin cancer or carcinoma in situ);

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Prior treatment with anti-PD-1, anti-PD-L1, or RANKL-targeting agents;
Active autoimmune disease requiring systemic therapy;
Presence of clinically uncontrollable pleural effusion/ascites effusion (subjects who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled);
Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
Presence of active bone metabolism disease (Paget bone disease, Cushing's syndrome, and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper/hypothyroidism, hyperparathyroidism/hypoparathyroidism;
Those who are known to be allergic to the active ingredients or excipients such as sintilimab, pemetrexed, nalusopaimab, carboplatin, cisplatin, paclitaxel, etc., of the drug in this study;
Have not recovered adequately from toxicity and/or complications induced by any of the interventions (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);
Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory department of the research center);
Hypocalcemia cannot be improved after treatment;
Previous or current osteomyelitis or osteonecrosis of the jaw; Dental surgery or oral surgery that does not heal; Acute dental or jaw disease requiring oral surgery; Those who plan to undergo invasive dental surgery during the study;
Use of any of the following anti-bone metabolizing agents within 6 months prior to enrollment: Parathyroid hormone (PTH) or derivatives; Calcitonin; Osteoprotein; Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1);
Pregnant or lactating women;
Presence of any serious or uncontrollable systemic disease, such as:
Resting ECG has major abnormalities in rhythm, conduction or morphology and severe symptoms that are difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation;
unstable angina, congestive heart failure, New York Heart Association (NYHA) classification ≥ grade 2 chronic heart failure;
myocardial infarction within 6 months prior to enrollment;
unsatisfactory blood pressure control;
History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current presence of clinically active interstitial lung disease;
active tuberculosis;
Presence of active or uncontrolled infection requiring systemic therapy;
Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
poorly controlled diabetes mellitus (fasting blood glucose (FBG) >10mmol/L);
Those whose urine routine showed a urine protein ≥++, and confirmed that the 24-hour urine protein was > 1.0 g;
Subjects with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other conditions that are considered by the investigator to be unsuitable for enrollment in the opinion of the investigator are not suitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhengfei Zhu contact

Wangjun Yan contact

China1 site, 1 recruiting

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zhengfei Zhu, +86-18017312901, fuscczzf@163.com
Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy Followed by First-line Chemotherapy Combined With Immunotherapy in Advanced Driver Gene-negative Non-small Cell Lung Cancer Patients With Bone Metastases: A Phase II, Single-arm, Single-center Clinical Trial Protocol

Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases.

Methods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR/PR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR/PR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%.

Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.

Conditions: NSCLC, Stereotactic Body Radiation Therapy (SBRT), Immunotherapy
Being tested: Narlumosbart, Stereotactic Body Radiation Therapy

What participants receive

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

NarlumosbartDrug
Also called chemotherapy, Stereotactic Body Radiation Therapy
Narlumosbart is a fully humanized anti-RANKL monoclonal antibody (IgG4) with Fab arms identical to denosumab, demonstrating rapid and sustained suppression of bone resorption biomarkers in patients with bone metastases. It will be administered subcutaneously at 120 mg every 4 weeks. Calcium and vitamin D supplementation will be given concurrently to prevent hypocalcemia. Adverse events will be recorded and graded according to CTCAE v5.0. For jaw osteonecrosis, all patients will undergo a mandatory dental examination within 14 days before the first dose, with 3-monthly dental checks during treatment; suspected cases will be managed with oral surgeon consultation. Serum calcium will be monitored at baseline and prior to each dose (every 4 weeks). Corrected calcium <2.0 mmol/L will be managed with oral calcium (500-1000 mg/day) and vitamin D (400-800 IU/day). Severe hypocalcaemia (<1.8 mmol/L or symptomatic) will be treated with intravenous calcium gluconate.
Stereotactic Body Radiation TherapyRadiation
SBRT will be delivered within one week before the first chemo-immunotherapy cycle. All patients undergo contrast-enhanced CT simulation (1-1.5 mm slice thickness); MRI fusion (T1/T2/STIR) is mandatory for spinal metastases. Target delineation: GTV = visible tumor on CT/MRI; CTV = involved vertebral body sector(s) per ISRC guidelines for spinal lesions, or GTV + 3-5 mm margin for non-spinal lesions; PTV = CTV + 1-2 mm margin. Dose prescription: 24 Gy in 3 fractions for spinal metastases; 30-35 Gy in 5 fractions for non-spinal lesions. Treatment plans use VMAT or IMRT. Daily cone-beam CT (CBCT) is performed before each fraction for image guidance; 6-degree-of-freedom couch corrections are used for spinal lesions. Respiratory motion management (e.g., 4D-CT, gating) is applied for mobile lesions if motion exceeds 5 mm. Patient-specific quality assurance (PSQA) is performed before the first fraction, with gamma analysis (3%/2 mm criteria and ≥95% passing rate) required.

Study groups in NCT06738160
Study group	Role	What they receive
Narlumosbart + SBRT	Experimental	This is a single-arm, phase II trial evaluating the efficacy and safety of narlumosbart (120 mg SC Q4W) combined with stereotactic body radiation therapy (SBRT) and standard first-line chemo-immunotherapy in driver gene-negative advanced NSCLC patients with bone metastases. Narlumosbart is an anti-RANKL mAb. SBRT dose: 24 Gy/3F for spinal lesions; 30-35 Gy/5F for non-spinal lesions, delivered 3 days prior to chemo-immunotherapy. Chemo-immunotherapy follows standard guidelines. Treatment continues until progression, toxicity, or withdrawal.The trial uses Simon two-stage design with H₀=25%, H₁=50%, α=0.05, power=0.8; 9 patients in stage 1, with ≥2 responses triggering stage 2 (+15 patients), and <2 responses stopping the trial. Total sample size is 27 including 10% dropout. A sensitivity analysis is pre-specified: if stage-1 ORR falls between 25% and 40%, protocol revision to H₁=40% with sample size adjustment will be considered, pending ethics approval. Receives: Drug: Narlumosbart; Radiation: Stereotactic Body Radiation Therapy

What is being measured

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

Objective response rate, ORR
Measured: 2 years

Secondary outcomes (6)

Incidence of AEs, SAEs, and AE-Related Treatment Discontinuation
To assess the frequency of adverse events (AEs), severe adverse events (SAEs), and treatment discontinuation caused by AEs or SAEs over the study period.
Measured: 2 years
Progression free survival, PFS
Progression-free survival (PFS) is defined as the time from randomization (or treatment initiation) to the earlier of the first documentation of objective disease progression (per RECIST v1.1) or death due to any caus
Measured: 2 years
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment initiation to death from any cause. Participants who are alive or lost to follow-up at the time of analysis will be censored at the date of their last known survival status.
Measured: 2 years
Incidence of bone-related events (SREs)
Incidence of bone-related events (SREs) is defined as the proportion of patients experiencing at least one skeletal-related event (SRE) within the specified time intervals (3, 6, and 12 months). SREs are defined as a composite endpoint including: pathological fracture, spinal cord compression, bone-directed radiotherapy or surgery, or hypercalcaemia of malignancy, as assessed by the investigator.
Measured: 2 years
Changes in pain score
Changes from baseline in pain score measured by the Brief Pain Inventory-Short Form (BPI-SF, 0-10, higher=worse).
Measured: 2 years
Changes in quality of life
EORTC QLQ-C30 measures global health, functions, and symptoms (0-100; higher=better for global/function, worse for symptoms) from baseline.
Measured: 2 years

Timeline

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

15 Feb 202530 Dec 2028

First posted17 Dec 2024
Study start15 Feb 2025
Primary completion30 Dec 2026 (estimated)
Study completion30 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NSCLCStudies of the same condition, open and under way.
More trials run by Fudan 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Model Description
Masking: None (open label)
Enrolment: 27 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06738160
Sponsor's protocol ID: 2024-NSCLC-SBRT
Other IDs: SACA-AX202407
Status last verified: Sep 2026
First submitted: 13 Dec 2024
Last updated: 11 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified IPD (baseline, efficacy, safety, and biomarker data) will be shared upon reasonable request after publication.

Publications

Li J, Zhou N, Lu S, Yang X, Yan W, Zhu Z, Cheng M. Efficacy and safety of narlumosbart in combination with stereotactic body radiation therapy followed by first-line chemotherapy combined with immunotherapy in advanced driver gene-negative non-small cell lung cancer patients with bone metastases: a phase II, single-arm, single-centre clinical trial protocol. BMJ Open. 2026 Oct 1;16(10):e120892. doi: 10.1136/bmjopen-2026-120892.
PubMed 42823111

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy Followed by First-line Chemotherapy Combined With Immunotherapy in Advanced Driver Gene-negative Non-small Cell Lung Cancer Patients With Bone Metastases: A Phase II, Single-arm, Single-center Clinical Trial Protocol
ClinicalTrials.gov ID: NCT06738160
Acronym / sponsor ID: 2024-NSCLC-SBRT
Conditions: NSCLC, Stereotactic Body Radiation Therapy (SBRT), Immunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 27 participants (estimated)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Study start: 15 Feb 2025 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Dec 2028 (estimated)
First posted: 17 Dec 2024 (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.

Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Model Description

Arm	Type	Receives
Narlumosbart + SBRT	Experimental	Drug: Narlumosbart, Radiation: Stereotactic Body Radiation TherapyThis is a single-arm, phase II trial evaluating the efficacy and safety of narlumosbart (120 mg SC Q4W) combined with stereotactic body radiation therapy (SBRT) and standard first-line chemo-immunotherapy in driver gene-negative advanced NSCLC patients with bone metastases. Narlumosbart is an anti-RANKL mAb. SBRT dose: 24 Gy/3F for spinal lesions; 30-35 Gy/5F for non-spinal lesions, delivered 3 days prior to chemo-immunotherapy. Chemo-immunotherapy follows standard guidelines. Treatment continues until progression, toxicity, or withdrawal.The trial uses Simon two-stage design with H₀=25%, H₁=50%, α=0.05, power=0.8; 9 patients in stage 1, with ≥2 responses triggering stage 2 (+15 patients), and <2 responses stopping the trial. Total sample size is 27 including 10% dropout. A sensitivity analysis is pre-specified: if stage-1 ORR falls between 25% and 40%, protocol revision to H₁=40% with sample size adjustment will be considered, pending ethics approval.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Signed informed consent prior to the implementation of any trial-related procedures;
Age 18-80 years old;
Histologically or cytologically confirmed stage IV NSCLC according to the TNM Classification of Malignant Tumours, 9th edition；
Histologically confirmed bone metastases requiring local radiotherapy；
Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);

Key exclusion criteria (32 listed)

The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
The lesion is an isolated lesion and can be treated radically;
Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;
The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after evaluation;
Presence of active brain metastases;

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
NarlumosbartAlso: chemotherapy, Stereotactic Body Radiation TherapyNarlumosbart is a fully humanized anti-RANKL monoclonal antibody (IgG4) with Fab arms identical to denosumab, demonstrating rapid and sustained suppression of bone resorption biomarkers in patients with bone metastases. It will be administered subcutaneously at 120 mg every 4 weeks. Calcium and vitamin D supplementation will be given concurrently to prevent hypocalcemia. Adverse events will be recorded and graded according to CTCAE v5.0. For jaw osteonecrosis, all patients will undergo a mandatory dental examination within 14 days before the first dose, with 3-monthly dental checks during treatment; suspected cases will be managed with oral surgeon consultation. Serum calcium will be monitored at baseline and prior to each dose (every 4 weeks). Corrected calcium <2.0 mmol/L will be managed with oral calcium (500-1000 mg/day) and vitamin D (400-800 IU/day). Severe hypocalcaemia (<1.8 mmol/L or symptomatic) will be treated with intravenous calcium gluconate.	Drug	Narlumosbart + SBRT
Stereotactic Body Radiation TherapySBRT will be delivered within one week before the first chemo-immunotherapy cycle. All patients undergo contrast-enhanced CT simulation (1-1.5 mm slice thickness); MRI fusion (T1/T2/STIR) is mandatory for spinal metastases. Target delineation: GTV = visible tumor on CT/MRI; CTV = involved vertebral body sector(s) per ISRC guidelines for spinal lesions, or GTV + 3-5 mm margin for non-spinal lesions; PTV = CTV + 1-2 mm margin. Dose prescription: 24 Gy in 3 fractions for spinal metastases; 30-35 Gy in 5 fractions for non-spinal lesions. Treatment plans use VMAT or IMRT. Daily cone-beam CT (CBCT) is performed before each fraction for image guidance; 6-degree-of-freedom couch corrections are used for spinal lesions. Respiratory motion management (e.g., 4D-CT, gating) is applied for mobile lesions if motion exceeds 5 mm. Patient-specific quality assurance (PSQA) is performed before the first fraction, with gamma analysis (3%/2 mm criteria and ≥95% passing rate) required.	Radiation	Narlumosbart + SBRT

Primary outcome

Objective response rate, ORR
Time frame: 2 years

6 secondary outcomes

Incidence of AEs, SAEs, and AE-Related Treatment Discontinuation
Time frame: 2 years
Progression free survival, PFS
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Incidence of bone-related events (SREs)
Time frame: 2 years
Changes in pain score
Time frame: 2 years
Changes in quality of life
Time frame: 2 years

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 11 Sep 2026.
Derived from this study: PubMed 42823111Li J, Zhou N, Lu S, Yang X, Yan W, Zhu Z, Cheng M. Efficacy and safety of narlumosbart in combination with stereotactic body radiation therapy followed by first-line chemotherapy combined with immunotherapy in advanced driver gene-negative non-small cell lung cancer patients with bone metastases: a phase II, single-arm, single-centre clinical trial protocol. BMJ Open. 2026 Oct 1;16(10):e120892. doi: 10.1136/bmjopen-2026-120892.
Individual participant dataSharing planned: Yes. De-identified IPD (baseline, efficacy, safety, and biomarker data) will be shared upon reasonable request after publication.

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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.

Zhengfei Zhu contact

Wangjun Yan contact

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 Narlumosbart and Stereotactic Body Radiation Therapy in people with NSCLC and Stereotactic Body Radiation Therapy (SBRT), run by Fudan University at 1 site in China.

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 11 inclusion and 32 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 11 Sep 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 China. 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 Zhengfei Zhu (+86-18017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate, ORR (time frame: 2 years). 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 NCT06738160, which also lists 1 linked publication.

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 11 Sep 2026.