Neuroendocrine TumorsPhase 2LUMOD-IDNCT06395402
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
A Phase 2 study testing Lutetium Lu 177 dotatate therapy in people with Neuroendocrine Tumors and Neuroendocrine Tumor Grade 1, run by University of Iowa at 1 site in United States.
Trial summary
The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2
- What is being tested?
- Lutetium Lu 177 dotatate therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 31 Dec 2029
- 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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged ≥ 18 years at time of consent.
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the primary tumor location known or believed to be gastroenteropancreatic origin (GEP-NET)
- Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that shows uptake > liver background on sstr2 PET/CT with any FDA approved sstr2 imaging agent. SSTR2 PET/CT must have been obtained within 90 days prior to scheduled C1D1 of Lutathera.
- Recommended to receive LUTATHERA® therapy for unresectable and/or metastatic neuroendocrine disease.
Show all 13Show fewer
- Adequate performance status (ECOG of 0 or 1; or Karnofsky performance status of ≥70).
- Agrees to contraception during therapy.
- Neutrophil count within normal limits within 28 days of treatment day 1.
- Platelet count within normal limits within 28 days of treatment day 1.
- Ability to take oral medication and be willing to adhere to the treatment regimen
- For individuals of reproductive potential: agreement to use effective birth control
- Agreement to adhere to Lifestyle Considerations throughout study duration: abstain from caffeine or xanthine-containing products as well as alcohol before the start of cycle dosing and through the cycle's final blood sample; minimize social interactions during low blood counts.
Who cannot join
- Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \& dump' strategy; lactation must be discontinued).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), fever, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
- Prior peptide-receptor radiotherapy (PRRT).
- Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).
- A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound/negatively impact study objectives (documentation of the rationale must be provided)
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- Prior external beam radiation dose to the kidneys of >10 Gy (mean dose to functional renal volume).
- Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan® or Netspot™.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa, 52242
Kristin Gaimari-Varner, RN, BSN, 319-384-9495, kristin-gaimari-varner@uiowa.edu
Kellie Bodeker, Ph.D., 319-384-9425, kellie-bodeker@uiowa.edu
About this study
The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will:
- Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET/CT scan
- Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry)
- Undergo blood tests for 4 to 8 weeks after each Lutathera treatment
- Complete patient reported outcome questionnaires
- Visit the clinic for follow-up about every 8 weeks.
Read the detailed description
This is a randomized controlled clinical trial evaluating the impact of forward planning dosimetry for Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals), a radiopharmaceutical approved to treat neuroendocrine tumors by the U.S. FDA.
If a patient consents to participate, and is deemed eligible to move forward, there is a 2 out of 3 chance to receive the investigational treatment (the Lutathera treatment customized to tumor uptake and kidney uptake). The standard treatment is 200 millicuries (mCi) of Lutathera per cycle, with potential adjustments for safety per the FDA-approved package insert.
Regardless of the assigned group (investigational treatment or standard treatment), the first treatment is 200 mCi. This is given with amino acids, which is required for this treatment.
Participants in the standard treatment continue to receive 200 mCi per treatment, with or without adjustment based on package insert instructions, for up to 4 treatments total.
Participants in the investigational treatment will receive a customized dose of Lutathera, up to 400 mCi per treatment for treatments 2 - 4, in the hopes that escalation will be safe and effective in many patients based on individualized dosimetry.
Participants randomized to the investigational treatment will receive specialized imaging (SPECT/CT) following administration of Lutathera. This will identify where the Lutathera went and how long it remains there (in the tumors, kidneys, or bone marrow). After the first dose of Lutathera, this imaging is done on the first day of treatment and then once a day for the next 3 to 4 days. Each scan lasts about an hour. Following treatments 2 and 3, this imaging is only done on the first day and then once at about 3 to 4 days after the treatment. There are also blood samples collected to measure the radioactivity in the blood.
All participants must be actively followed to assess for side effects of therapy as well as treatment outcomes. This means participants must return to the treatment site at 2, 3, 6, and 12 months after the last cycle of therapy. All participants must have a CT scan completed at 6 months after treatment as well.
Radiation side effects can take years to develop. For this reason, it is very important that participants remain in touch with the study investigator and team. Participants have life-long follow-up for this study.
- Being tested
- Lutetium Lu 177 dotatate therapy
- Keywords
- lutetium Lu 177 dotatate, Radiotherapy Planning, Computer-Assisted
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium Lu 177 dotatate therapyDrug
Also called Lutathera
LUTATHERA is an FDA approved radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumor (GEP-NET). This radiopharmaceutical binds to somatostatin receptors, which are overexpressed on GEP-NET cells, and subsequently delivers beta particle radiation to the tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| Dosimetry-based lutetium Lu 177 dotatate therapy | Experimental | Intravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles.
Intended administered radioactivity:
Cycle 1: 200 millicuries (mCi) Cycles 2, 3, and 4: based upon dosimetry for radiation exposure to bone marrow (no more than 1 Gy per administration) and kidneys (maximum dose 28 Gy total). Not to exceed 400 millicuries (mCi) per cycle (1400 mCi maximum for all cycles). Receives: Drug: Lutetium Lu 177 dotatate therapy |
| Standard lutetium Lu 177 dotatate | Active comparator | Intravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Each cycle is intended to receive 200 millicuries of radioactivity for a total treatment of 800 millicuries. Receives: Drug: Lutetium Lu 177 dotatate therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) at 6 months after treatment
Determine objective response rate in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) treated with dosimetrically-determined LUTATHERA administration compared to active control.
Measured: 6 months after completion of treatment
Secondary outcomes (3)
Treatment emergent toxicity assessment
Determine treatment-emergent toxicity, as graded by the NCI's Common Terminology Criteria for Adverse Events (CTCAE) version 5 in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumor (GEPNET) treated with dosimetrically derived Lutathera compared to standard treatment. Endpoints are Incidence and severity of toxicities
Measured: From treatment day 1 every 6 months for 5 years post-treatment
Time to disease progression
Determine time to progression in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumor (GEPNET) treated with dosimetrically derived Lutathera compared to standard treatment
Measured: Up to 5 years post-treatment
Correlation of hematologic toxicities
Assess correlation between hematologic toxicity and bone marrow dose in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumor (GEPNET) treated with dosimetrically derived LUTATHERA compared to active control
Measured: At 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start3 May 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Stephen A. Graves, University of Iowa
- Investigators
- Stephen Graves, Ph.D., DABR, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395402
- Sponsor's protocol ID
- 202208502
- Acronym
- LUMOD-ID
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will only be shared if the trial participant has consented to sharing. Trial data to share: imaging (CT, PET, MRI), dosimetry plans, participant demographics (race, ethnicity, age at consent), disease stage, organ contours for dosimetry, lutathera prescription, treatment history, concomitant medications, and dose modification and holds. Protocol, blank case report forms, and statistical analysis plan will be retained and shared. Imaging data are shared DICOM format. Adverse events will be categorized utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Publications
Park EA, Graves SA, Menda Y. The Impact of Radiopharmaceutical Therapy on Renal Function. Semin Nucl Med. 2022 Jul;52(4):467-474. doi: 10.1053/j.semnuclmed.2022.02.004. Epub 2022 Mar 18.
PubMed 35314056Soulek DK, Mastascusa NJ, Martin ME, Graves SA. Practical Considerations for Implementation of 177Lu-DOTATATE Neuroendocrine Tumor Treatment Programs. J Nucl Med Technol. 2022 Sep 1;50(3):195-202. doi: 10.2967/jnmt.122.263813. Epub 2022 Jun 14.
PubMed 35701215Capala J, Graves SA, Scott A, Sgouros G, James SS, Zanzonico P, Zimmerman BE. Dosimetry for Radiopharmaceutical Therapy: Current Practices and Commercial Resources. J Nucl Med. 2021 Dec;62(Suppl 3):3S-11S. doi: 10.2967/jnumed.121.262749.
PubMed 34857621Sgouros G, Dewaraja YK, Escorcia F, Graves SA, Hope TA, Iravani A, Pandit-Taskar N, Saboury B, James SS, Zanzonico PB. Tumor Response to Radiopharmaceutical Therapies: The Knowns and the Unknowns. J Nucl Med. 2021 Dec;62(Suppl 3):12S-22S. doi: 10.2967/jnumed.121.262750.
PubMed 34857617
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
- ClinicalTrials.gov ID
- NCT06395402
- Acronym / sponsor ID
- LUMOD-ID / 202208502
- Keywords
- lutetium Lu 177 dotatate, Radiotherapy Planning, Computer-Assisted
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 3 May 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 May 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.
The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will:
- Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET/CT scan
- Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry)
- Undergo blood tests for 4 to 8 weeks after each Lutathera treatment
- Complete patient reported outcome questionnaires
- Visit the clinic for follow-up about every 8 weeks.
Detailed description
This is a randomized controlled clinical trial evaluating the impact of forward planning dosimetry for Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals), a radiopharmaceutical approved to treat neuroendocrine tumors by the U.S. FDA.
If a patient consents to participate, and is deemed eligible to move forward, there is a 2 out of 3 chance to receive the investigational treatment (the Lutathera treatment customized to tumor uptake and kidney uptake). The standard treatment is 200 millicuries (mCi) of Lutathera per cycle, with potential adjustments for safety per the FDA-approved package insert.
Regardless of the assigned group (investigational treatment or standard treatment), the first treatment is 200 mCi. This is given with amino acids, which is required for this treatment.
Participants in the standard treatment continue to receive 200 mCi per treatment, with or without adjustment based on package insert instructions, for up to 4 treatments total.
Participants in the investigational treatment will receive a customized dose of Lutathera, up to 400 mCi per treatment for treatments 2 - 4, in the hopes that escalation will be safe and effective in many patients based on individualized dosimetry.
Participants randomized to the investigational treatment will receive specialized imaging (SPECT/CT) following administration of Lutathera. This will identify where the Lutathera went and how long it remains there (in the tumors, kidneys, or bone marrow). After the first dose of Lutathera, this imaging is done on the first day of treatment and then once a day for the next 3 to 4 days. Each scan lasts about an hour. Following treatments 2 and 3, this imaging is only done on the first day and then once at about 3 to 4 days after the treatment. There are also blood samples collected to measure the radioactivity in the blood.
All participants must be actively followed to assess for side effects of therapy as well as treatment outcomes. This means participants must return to the treatment site at 2, 3, 6, and 12 months after the last cycle of therapy. All participants must have a CT scan completed at 6 months after treatment as well.
Radiation side effects can take years to develop. For this reason, it is very important that participants remain in touch with the study investigator and team. Participants have life-long follow-up for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dosimetry-based lutetium Lu 177 dotatate therapy | Experimental | Drug: Lutetium Lu 177 dotatate therapyIntravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Intended administered radioactivity: Cycle 1: 200 millicuries (mCi) Cycles 2, 3, and 4: based upon dosimetry for radiation exposure to bone marrow (no more than 1 Gy per administration) and kidneys (maximum dose 28 Gy total). Not to exceed 400 millicuries (mCi) per cycle (1400 mCi maximum for all cycles). |
| Standard lutetium Lu 177 dotatate | Active comparator | Drug: Lutetium Lu 177 dotatate therapyIntravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Each cycle is intended to receive 200 millicuries of radioactivity for a total treatment of 800 millicuries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged ≥ 18 years at time of consent.
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the primary tumor location known or believed to be gastroenteropancreatic origin (GEP-NET)
- Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that shows uptake > liver background on sstr2 PET/CT with any FDA approved sstr2 imaging agent. SSTR2 PET/CT must have been obtained within 90 days prior to scheduled C1D1 of Lutathera.
Key exclusion criteria (9 listed)
- Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \& dump' strategy; lactation must be discontinued).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), fever, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
- Prior peptide-receptor radiotherapy (PRRT).
- Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).
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 |
|---|---|---|
| Lutetium Lu 177 dotatate therapyAlso: LutatheraLUTATHERA is an FDA approved radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumor (GEP-NET). This radiopharmaceutical binds to somatostatin receptors, which are overexpressed on GEP-NET cells, and subsequently delivers beta particle radiation to the tumor cells. | Drug | Dosimetry-based lutetium Lu 177 dotatate therapy, Standard lutetium Lu 177 dotatate |
Primary outcome
Objective Response Rate (ORR) at 6 months after treatment
Time frame: 6 months after completion of treatment
Determine objective response rate in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) treated with dosimetrically-determined LUTATHERA administration compared to active control.
3 secondary outcomes
Treatment emergent toxicity assessment
Time frame: From treatment day 1 every 6 months for 5 years post-treatment
Time to disease progression
Time frame: Up to 5 years post-treatment
Correlation of hematologic toxicities
Time frame: At 6 months post-treatment
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 22 Jul 2025.
- Background: PubMed 35314056Park EA, Graves SA, Menda Y. The Impact of Radiopharmaceutical Therapy on Renal Function. Semin Nucl Med. 2022 Jul;52(4):467-474. doi: 10.1053/j.semnuclmed.2022.02.004. Epub 2022 Mar 18.
- Background: PubMed 35701215Soulek DK, Mastascusa NJ, Martin ME, Graves SA. Practical Considerations for Implementation of 177Lu-DOTATATE Neuroendocrine Tumor Treatment Programs. J Nucl Med Technol. 2022 Sep 1;50(3):195-202. doi: 10.2967/jnmt.122.263813. Epub 2022 Jun 14.
- Background: PubMed 34857621Capala J, Graves SA, Scott A, Sgouros G, James SS, Zanzonico P, Zimmerman BE. Dosimetry for Radiopharmaceutical Therapy: Current Practices and Commercial Resources. J Nucl Med. 2021 Dec;62(Suppl 3):3S-11S. doi: 10.2967/jnumed.121.262749.
- Background: PubMed 34857617Sgouros G, Dewaraja YK, Escorcia F, Graves SA, Hope TA, Iravani A, Pandit-Taskar N, Saboury B, James SS, Zanzonico PB. Tumor Response to Radiopharmaceutical Therapies: The Knowns and the Unknowns. J Nucl Med. 2021 Dec;62(Suppl 3):12S-22S. doi: 10.2967/jnumed.121.262750.
- Individual participant dataSharing planned: Yes. Data will only be shared if the trial participant has consented to sharing. Trial data to share: imaging (CT, PET, MRI), dosimetry plans, participant demographics (race, ethnicity, age at consent), disease stage, organ contours for dosimetry, lutathera prescription, treatment history, concomitant medications, and dose modification and holds. Protocol, blank case report forms, and statistical analysis plan will be retained and shared. Imaging data are shared DICOM format. Adverse events will be categorized utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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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.
Stephen Graves, Ph.D., DABR principal investigator
University of Iowa
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 Lutetium Lu 177 dotatate therapy in people with Neuroendocrine Tumors and Neuroendocrine Tumor Grade 1, run by University of Iowa 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 13 inclusion and 9 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 22 Jul 2025. 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 Stephen A Graves, Ph.D., DABR (+1 319 356 3656, stephen-a-graves@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) at 6 months after treatment (time frame: 6 months after completion of treatment). 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 NCT06395402, which also lists 4 linked publications.
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 22 Jul 2025.