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Extensive Stage Lung Small Cell CarcinomaPhase 2NCT07423585

Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Extensive Stage Lung Small Cell Carcinoma, run by Asrar Alahmadi at 1 site in United States.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial tests the effect of tarlatamab in treating patients with small-cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer that has a low 5-year survival rate. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
20 Mar 2026to 31 Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
  • NOTE: HIPAA authorization may be included in the informed consent or obtained separately
  • Age ≥ 18 years at the time of consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2
  • Have a histologically or cytologically documented new diagnosis of the extensive-stage (i.e., metastatic and/or recurrent) SCLC. Patients with multiple lung nodules and/or lymph node involvement that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan are allowed
  • Recurrent limited-stage SCLC disease after 6 months of completing standard-of-care systemic platinum-based chemotherapy and radiation can be considered after discussion with the sponsor
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  • Measurable disease according to RECIST v 1.1
  • All patients must have brain MRI. Subjects with brain metastases are eligible provided they meet the following criteria:
  • Patients with treated brain metastases are eligible if they completed definitive therapy at least 1 week prior to the first dose of tarlatamab, are asymptomatic (unless symptoms are deemed irreversible by the investigator), and on stable dose of steroids (=< 10 mg prednisone equivalent) for at least 7 days prior to study treatment
  • Patients with asymptomatic untreated brain metastases with no radiological evidence of vasogenic edema may be considered for inclusion after discussion with the sponsor
  • Absolute neutrophil count (ANC) ≥ 1500 cells/uL
  • Platelets ≥ 100,000/uL
  • Hemoglobin ≥ 9.0 g/dL
  • Lymphocyte count ≥ 500/uL
  • Estimated glomerular filtration rate (eGFR) based on MDRD (Modification of Diet in Renal Disease) calculation ≥ 30 mL/min/1.73 m^2
  • Total bilirubin < 1.5 x upper limit of normal (ULN) (or < 2 x ULN for subjects with liver metastases, or < 3 x ULN for subjects with known Gilbert disease)
  • Aspartate aminotransferase (AST) < 3 x ULN (or < 5 x ULN for subjects with liver involvement)
  • Alanine aminotransferase (ALT) < 3 x ULN (or < 5 x ULN for subjects with liver involvement)
  • Alkaline phosphatase (ALP) < 3 x ULN (or < 5 x ULN for subjects with liver involvement)
  • Albumin ≥ 2.5 g/dL
  • Patients with indwelling catheters (e.g., PleurX®) are allowed
  • Baseline oxygen saturation ≥ 90% on room air
  • Chronic obstructive pulmonary disease (COPD) patients on stable supplementary oxygen (O2) for at least 6 months may be considered for inclusion after discussion with the sponsor
  • Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no clinically significant electrocardiogram (ECG) findings
  • As determined by the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
  • Availability of archival tissue, preferably a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (or ideally at least 15 newly cut unstained slides). For eligibility, only confirmation of archival tissue is needed. Verification of tumor burden in the biopsy is encouraged. For optimal biomarker results, tumor content should be > 30% of total tissue area
  • Be willing to provide peripheral blood samples at specified time-points during the study

Who cannot join

  • Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment
  • Patients with a prior or concurrent malignancy whose natural history or treatment could potentially interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
  • Symptomatic brain metastases and/or leptomeningeal disease
  • Clinically significant cardiovascular disease per the investigator. Examples include unstable arrhythmia, unstable angina, myocardial infarction, and/or symptomatic congestive heart failure (New York Heart Association class II) within 3 months of the first dose of tarlatamab
  • Current history of active and uncontrolled central nervous system (CNS) disease, such as stroke, transient ischemic attack, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits as judged by the investigator are permitted to enroll
Show all 36Show fewer
  • Patients with a history of epilepsy who have had controlled symptoms and no seizures in the past 2 years are allowed
  • Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab administration
  • Subject has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint
  • NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile for > 72 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as an exclusion criterion
  • Subjects with active hepatitis or HIV infection, testing is required
  • Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of hepatitis B virus surface antigen [HBsAg]) are eligible
  • In patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Subjects with HIV/AIDS with adequate antiviral therapy to control viral load (i.e., undetectable) and lymphocyte count would be allowed if they are stable and have been on treatment for ≥ 4 weeks prior to the first dose of study drug(s)
  • Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy
  • Subject has known sensitivity and immediate hypersensitivity to any components of tarlatamab
  • Prior treatment for SCLC. Subjects with limited-stage SCLC (LS-SCLC) who progressed after 6 months from completing chemotherapy and radiation may be considered for inclusion after discussion with the sponsor
  • Palliative radiotherapy is allowed to non-target lesions, and must have been completed at least 7 days prior to the first dose of tarlatamab
  • Subjects with irreversible toxicity (defined as having been present and stable for > 21 days) that, in the opinion of the treating physician, is not reasonably expected to be exacerbated by the investigational product may be included (e.g., neuropathy, alopecia, hearing loss, hormone deficiency requiring replacement therapy)
  • Subjects who received major surgery within 30 days. Subjects must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Subjects with known active autoimmune disease or immune deficiency that has required systemic treatment or steroids (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
  • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
  • Physiologic doses of steroids are permitted
  • Subjects with a known history of solid organ transplantation
  • Subjects with evidence of interstitial lung disease or active, non-infectious pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Subjects with history of radiation pneumonitis in the radiation field (fibrosis) are permitted
  • Subjects with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Live and live attenuated vaccination are prohibited within 28 days prior to the first dose of tarlatamab treatment and for the duration of study. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination should be avoided during screening at least 14 days prior to the first day of tarlatamab treatment
  • Subjects of both genders of child-bearing potential who are not willing to practice an acceptable method(s) of effective birth control while on study, and through 60 days (for female subjects) or through 60 days (for male subjects) after receiving last dose of tarlatamab
  • Females who are pregnant or planning to become pregnant or breastfeeding or who plan to breastfeed while on study through 60 days after receiving the last dose of tarlatamab. Subjects who are willing to suspend breastfeeding prior to starting treatment with tarlatamab and do not intend to resume breastfeeding 60 days after receiving the last dose of tarlatamab can be enrolled.
  • Males who are unwilling to abstain from sperm donation while on study and through 60 days after receiving the last dose of tarlatamab
  • Symptomatic pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Patients with indwelling catheters (e.g., PleurX) are allowed
  • Subjects with uncontrolled respiratory symptoms or concern about impending respiratory failure due to tumor compression requiring urgent intervention
  • Subjects with a history or current evidence of clinically significant disease, condition, therapeutic intervention, or laboratory abnormality that would pose a risk to subject safety and might confound the study evaluation, procedures or completion or may interfere with the subject's participation for the full duration of the trial, in the opinion of the treating investigator

Trial locations and contacts

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

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Asrar AlAhmadi, MBBS, 614-293-6786, Asrar.Alahmadi@osumc.edu

    Asrar AlAhmadi, MBBS

    Recruiting

Other trials in United States

About this study

Official title: A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer

This phase II trial tests the effect of tarlatamab in treating patients with small-cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer that has a low 5-year survival rate. Tarlatamab is a bispecific antibody that can bind to two different antigens at the same time. Tarlatamab binds to DLL3, a protein found on the surface of some types of tumor cells, including small-cell lung cancer, and to CD3, which is present on immune system T-cells (a type of white blood cell), and may interfere with tumor cell ability to grow and spread. This may increase the time to progression (growing, spreading, or worsening) and help patients with extensive-stage SCLC live longer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the 6-month progression-free survival (PFS) rate for extensive-stage SCLC (ES-SCLC) patients treated with tarlatamab as first-line therapy.

II. Interim analysis for futility monitoring: To monitor the rate of rapid disease progression (PD) at 4 weeks, with a goal of < 40%.

SECONDARY OBJECTIVES:

  1. To evaluate the safety and toxicity of tarlatamab as first-line therapy for ES-SCLC using National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) version 5.0 for all adverse events (AEs) and the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Criteria for cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

II. To assess objective response rate (ORR), duration of response (DOR), and disease control rate (DCR) in ES-SCLC patients treated with tarlatamab in first-line settings as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.

III. To evaluate the intracranial (ic) antitumor activity of tarlatamab as first-line therapy in ES-SCLC with baseline brain metastasis as measured by ic best ORR, time to intracranial response, icDOR, and icPFS rate at 6 months.

IV. To assess median PFS, 12-month overall survival (OS), and median OS in ES-SCLC patients treated with tarlatamab in first-line settings.

EXPLORATORY OBJECTIVES:

  1. To assess quality of life (QoL) as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) QOL.

II. To assess the clinical efficacy of platinum-based chemotherapy (PC) and immune checkpoint inhibitors (ICI) in second-line settings (progression on tarlatamab) as measured by time to second progression (PFS2).

III. To measure the time to initiation of PC and ICI in ES-SCLC (after disease progression on tarlatamab).

OUTLINE:

Patients receive tarlatamab intravenously (IV) over 60 minutes on days 1, 8, and 15 of cycle 1, then on days 1 and 15 of remaining cycles. Cycles repeat every 28 days unless disease progression or unacceptable toxicity occurs.

Patients receive a safety response assessment scan after 4 weeks of starting treatment. Patients with rapid disease progression will immediately start standard of care platinum-based chemotherapy and immune checkpoint inhibitors. Response assessment scans will be done every 8 weeks (2 cycles).

After completion of study treatment, patients are followed at 30 days, then every 3 months for up to 2 years.

Being tested
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test, Electronic Health Record Review
Keywords
tarlatamab, Small cell lung cancer, extensive stage small cell lung cancer, window of opportunity
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo biopsies

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo computed tomography

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Questionnaire AdministrationOther

    Ancillary studies

  • TarlatamabDrug

    Also called AMG 757, AMG-757, AMG757, Anti-DLL3 x Anti-CD3 BiTE AMG 757

    Given IV

Study groups in NCT07423585
Study groupRoleWhat they receive
Treatment (tarlatamab)ExperimentalPatients receive tarlatamab IV over 60 minutes on days 1, 8, and 15 of cycle 1, then on days 1 and 15 of remaining cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Other: Questionnaire Administration; Drug: Tarlatamab

What is being measured

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

  1. 6-month progression-free survival (PFS)

    Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death as a result of any cause. Will be calculated as the proportion of patients who are progression-free and alive divided by the total number of evaluable patients. Exact binomial 95% confidence intervals (CIs) for the 6-month PFS true rate will be calculated.

    Measured: From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months

  2. Rapid progressive disease (PD) on tarlatamab rate probability (Interim analysis for futility monitoring)

    Will be measured by RECIST v 1.1. Will be measured by the proportion of patients who have clinical and rapid clinical and radiological progression and move on to receive subsequent standard of care platinum-based chemotherapy and immune checkpoint inhibitors divided by the total number of evaluable patients. Exact binomial 95% CIs for the tarlatamab failure true rate will be calculated.

    Measured: Within 4 weeks of starting tarlatamab

Secondary outcomes (11)

  1. Rate of all adverse events (AEs)

    Will be summarized using National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0. Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial.

    Measured: Up to 30 days after last dose of study treatment

  2. Rate of all cytokine release syndrome

    Will be measured using American Society for Transplantation and Cellular Therapy (ASTCT). Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial.

    Measured: Up to 30 days after last dose of study treatment

  3. Rate of all immune effector cell associated neurotoxicity syndrome

    Will be measured using ASTCT. Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial.

    Measured: Up to 30 days after last dose of study treatment

  4. Overall objective response rate (ORR)

    Will be calculated by the proportion of patients with confirmed complete response (CR) or partial response (PR) using RECIST v 1.1 divided by the total number of evaluable patients. Exact binomial 95% CIs for the true PR + CR response rate will be calculated.

    Measured: Up to 2 years after last dose of study treatment

  5. Duration of response (DOR)

    Will be determined using RECIST v 1.1. The Kaplan-Meier method will be used to estimate DOR. Median with 95% CI will be calculated.

    Measured: From first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever comes first, assessed up to 2 years after last dose of study treatment

  6. Disease control rate

    Will be calculated as the proportion of patients with stable disease (SD), PR or CR according to RECIST v 1.1 divided by the total number of evaluable patients. Exact binomial 95% CIs for the true SD + PR + CR response rate will be calculated.

    Measured: Up to 2 years after last dose of study treatment

  7. Intracranial PFS rate (icPFS)

    Will be defined as the percentage of patients without intracranial disease progression including development of new lesions, development of symptomatic lesions or leptomeningeal disease, or intervention required for disease control (such as radiation or surgery). The Kaplan-Meier method will be used to estimate icPFS. Median with 95% CI will be calculated.

    Measured: From initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months

  8. Best intracranial ORR

    Will be defined as the best overall intracranial response across all efficacy assessments, based on up to 5 measurable intracranial lesions (as per RECIST 1.1 criteria for measurable/target lesions) as well as unmeasurable and new intracranial disease per RECIST 1.1 principles.

    Measured: From start of investigational therapy to the first documented objective intracranial response, assessed up to 2 years after last dose of study treatment

  9. Median PFS

    Progression will be defined by RECIST v 1.1. The Kaplan-Meier method will be used to estimate PFS. Median with 95% CI will be calculated.

    Measured: From initiation of investigational therapy until criteria for disease progression is met or death as a result of any cause, assessed up to 2 years after last dose of study treatment

  10. Overall survival (OS)

    The Kaplan-Meier method will be used to estimate OS. Median with 95% CI will be calculated.

    Measured: From initiation of investigational therapy to date of death from any cause, assessed up to 12 months

  11. OS in patients treated with tarlatamab in first-line settings

    Will be defined as the percentage of patients alive. The Kaplan-Meier method will be used to estimate OS. Median with 95% CI will be calculated.

    Measured: From initiation of investigational therapy to death as a result of any cause, assessed up to 12 months

Timeline

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

  1. First posted20 Feb 2026
  2. Study start20 Mar 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07423585
Sponsor's protocol ID
OSU-25028
Other IDs
NCI-2026-00832, OSU-25028
Status last verified
Jul 2026
First submitted
13 Feb 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Extensive Stage Lung Small Cell Carcinoma, run by Asrar Alahmadi 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 27 inclusion and 36 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 6 Jul 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 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 The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month progression-free survival (PFS) (time frame: From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months). 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?

On the ClinicalTrials.gov record for NCT07423585.

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 Jul 2026.

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