NSCLC (Non-small Cell Lung Cancer)Phase 2HYPERBOLICNCT07274384
Hyperprogression in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial
A Phase 2 study testing chemotherapy plus cemiplimab and Cemiplimab in people with NSCLC (Non-small Cell Lung Cancer) and Hyperprogression, run by Università Vita-Salute San Raffaele.
Trial summary
In metastatic NSCLC patients with PD-L1 expression ≥50%, a circulating immature (CD10-) LDNs level of ≥30.5% confers a high risk of hyperprogression (HPD) with first line single-agent immune-checkpoint inhibitors (SA-ICI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), Hyperprogression
- What is being tested?
- chemotherapy plus cemiplimab and Cemiplimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2030
- 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
- The participant (or legally acceptable representative) has provided documented informed consent to participation to the study and data protection consent form.
- Male or female aged 18 years or older.
- ECOG Performance Status of 0 - 2.
- Pathologically (histologically or cytologically) confirmed diagnosis of stage IV NSCLC (TNM 8th edition), who received no prior systemic treatment for recurrent or metastatic NSCLC. Mixed squamous/non-squamous tumors are eligible.
- PD-L1 TPS ≥ 50% (by local test).
- Absence of targetable oncogene alterations (EGFR, ALK, ROS1).
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- Circulating CD10- LDNs >30.5% at screening. LDNs will be defined as CD11b+CD15+ cells among live PBMC. Flow cytometry raw data will be centrally analyzed by the coordinating center.
- Measurable disease (RECIST 1.1) on two CT scans performed before randomization. The following criteria must be fulfilled:
- Participants must have at least one measurable lesion that has not been previously treated with radiotherapy.
- Chest and abdomen scans are mandatory
- Availability of measurable disease scans to be anonymized and sent for central independent confirmation by a radiologist of the coordinating center.
- A minimum 2-week interval and a maximum 12-week interval will be acceptable between the two pre-treatment CT scans.
- Availability to perform the baseline scan within a maximum 4-week interval before treatment start.
- Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count > 1.5 x 109/L (1500/mm3)
- Platelets ≥100 x 109/L (100 000/mm3)
- Haemoglobin ≥9.0 g/dL (5.59 mmol/L)
- Estimated glomerular filtration rate (according to CDK-EPI equation): ≥ 60ml/min/1.73 m2 for patients receiving cisplatin; ≥30 ml/min/1.73 m2 for patients receiving carboplatin.
- Serum bilirubin ≤1.5 x upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.
- AST and ALT ≤2.5 x ULN.
- Absence of a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or cemiplimab and/or to any of their excipients
Who cannot join
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication
- Known uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent). No serological testing is required unless mandated by local health authority.
- Administration of live or live-attenuated vaccines within 30 days before the baseline LDNs assessment. Administration of killed vaccines is allowed. Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
- Administration of radiotherapy within 7 days prior to the baseline LDNs assessment.
- Administration of colony-stimulating factors (e.g., G-CSF, GM-CSF) or recombinant erythropoietin within 28 days prior to the baseline LDNs assessment. Primary prophylaxis with G-CSF and pegylated G-CSF is not allowed. Secondary prophylaxis is not recommended and required case-by-case discussion with the coordinator center before G-CSF administration.
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- Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.
- Female patients who are pregnant, breast-feeding, male, or female patients of reproductive potential who are not employing an highly effective method of birth control.
- Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of patient safety or study results.
- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment (Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable).
- Allogenic tissue/solid organ transplant.
About this study
Official title: Hyperprogression Upon Cemiplimab Alone or With Chemotherapy in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial - HYPERBOLIC Trial
In metastatic NSCLC patients with PD-L1 expression ≥50%, a circulating immature (CD10-) LDNs level of ≥30.5% confers a high risk of hyperprogression (HPD) with first line single-agent immune-checkpoint inhibitors (SA-ICI). HPD is defined as a tumor growth rate (TGR) delta ≥50% between pre-treatment and post-treatment, and/or a TGR ratio ≥2. The combination of platinum-based chemotherapy (PCT) with ICI in this setting could prevent the occurrence of HPD and ultimately improve survival outcomes.
This randomized, multicentric, open-label, phase 2 trial will include patients with stage IV NSCL, without targetable oncogene drivers, PD-L1 TPS≥50%, and measurable disease on two CT scans performed before randomization. Participants will be randomized 1:1 to SA-ICI or ICI+PCT. Radiological evaluation will be performed by CT-scan at 6-8 weeks and subsequently according to the local investigators' schedule.
Read more
In the SA-ICI arm, ICI regimen will include cemiplimab. In the PCT+ICI arm, PCT regimens will include both carboplatin or cisplatin + pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab.
PCT will be administered for three cycles. In case of stable disease or partial response according to RECIST v.1.1, cemiplimab will be performed as monotherapy from the third cycle until disease progression or unacceptable toxicity. If progression according to RECIST v.1.1 or HPD after three cycles of PCT+ICI, patients will be treated with standard second line therapy as local standard of care.
Read the detailed description
Intervention: PCT plus cemiplimab for 3 cycles followed by cemiplimab in case of absence of PD/HPD. PCT regimens will include both carboplatin (area under the concentration-time curve, 5 mg per milliliter per minute) or cisplatin (75 mg per square meter of body surface area) plus pemetrexed (500 mg per square meter) for non-squamous histology or paclitaxel (200 mg per square meter) for squamous histology. All drugs in the PCT regimens will be administered intravenously every 3 weeks. Cemiplimab 350 mg "flat dose" will be administered intravenously every 3 weeks. Treatment will continue for a maximum of 108 weeks or until progression or unacceptable toxicity.
Comparator: Single-agent cemiplimab. Cemiplimab 350 mg "flat dose" will be administered intravenously every 3 weeks for 108 weeks or until progression or unacceptable toxicity.
Efficacy criteria: The rate of patients experienced HPD or ED will be calculated for both treatment arms.1 HPD is defined as a delta of tumor growth rate (TGR) ≥50% and/or a TGR ratio ≥2. TGR will be computed using RECIST v.1.1 on three consecutive, centrally revised, CT scans (two CT scans before treatment start and one after 7 week ± 5 days from treatment start).
Central review of CT scans will be performed before treatment start and after the first radiological evaluation (before third cycle). RECIST response after the second cycles will be decided according to central review.
ED is defined as tumor-related death within 12 weeks from ICI initiation, in absence of a radiological evaluation performed during ICI.
HPD rate according to definitions proposed by Lo Russo et al., Matos et al.et Saâd-Bouzid et al., will be evaluated as a secondary endpoint.
Efficacy parameters: After the first radiological evaluation performed at 7 weeks ± 5 days from treatment start, subjects will be evaluated by CT scans every 12 weeks ± 28 days according to local investigators' schedule.
CT scans are to be performed until disease progression or until the start of new anticancer treatment, withdrawal of consent, or death, whichever occurs first.
Per RECIST 1.1, the partial and complete response should be confirmed by a repeat tumor imaging assessment not less than 4 weeks from the date the response was first documented.
The enrollment period will last 48 months. The approximate duration of the active study assessments for each patient, including the screening phase, will be 3 months (the time required to confirm HPD occurrence or not). The duration of the active portion of the study will be 48 months, followed by and additional 3 months of follow-up, for a total of 51 months. In both arms, patients will receive treatment for a maximum of 108 weeks or until disease progression or unacceptable toxicity occurs. After the active portion of the study is completed, all patients will be followed for survival.
- Being tested
- chemotherapy plus cemiplimab, Cemiplimab
- Keywords
- lung, cancer, hyperprogression, chemotherapy, immunotherapy, carboplatin, cisplatin, pemetrexed, paclitaxel, cemiplimab, risk, immune-checkpoint inhibitors, ldns, CD10-, nsclc, PD-L1, randomized, open-label, Lung Immune Prognostic Index, recist
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy plus cemiplimabCombination product
Also called cemiplimab, carboplatin, cisplatin, pemetrexed
Combination of platinum-based chemotherapy (PCT) with ICI. PCT regimens will include both carboplatin or cisplatin plus pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab. PCT will be administered for three cycles.
CemiplimabDrug
Also called libtayo
single-agent immune-checkpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| single-agent immune-checkpoint inhibitors | Active comparator | single-agent immune-checkpoint inhibitors (SA-ICI) (Cemiplimab) Receives: Drug: Cemiplimab |
| PCT regimens + immune-checkpoint inhibitors | Experimental | PCT regimens will include both carboplatin or cisplatin plus pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab Receives: Combination Product: chemotherapy plus cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPD rate
HPD rate, defined as the proportion of patients with a delta of TGR ≥50% or a TGR ratio ≥2 at 7 weeks ± 5 days from randomization
Measured: up to HPD, end of treatment for a maximum of 108 weeks whichever comes first
ED rate
ED rate: who died without undergoing a scan after treatment initiation.
Measured: up to ED, end of treatment for a maximum of 108 weeks whichever comes first
Secondary outcomes (4)
Overall survival (OS)
To compare the activity of cemiplimab+PCT relative to cemiplimab alone.
Measured: up to HPD, ED, end of treatment for a maximum of 108 weeks whichever comes first
Progression free survival (PFS)
To compare the activity and efficacy of cemiplimab+PCT relative to cemiplimab alone
Measured: up to HPD, ED, end of treatment for a maximum of 108 weeks whichever comes first
Objective response rate (ORR)
To compare the activity of cemiplimab+PCT relative to cemiplimab alone.
Measured: up to HPD, ED, end of treatment for a maximum of 108 weeks whichever comes first
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Summary of adverse events (AE), with a focus on TRAEs coded based upon the Medical Dictionary for Regulatory Activities (MedDRA) and graded based upon CTCAE, ver. 5.0.
Measured: up to 90 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies 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, open-label
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Responsible party
- Principal investigator, Roberto Ferrara, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274384
- Sponsor's protocol ID
- 2025-521583-35-00
- Other IDs
- 2025
- Acronym
- HYPERBOLIC
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperprogression Upon Cemiplimab Alone or With Chemotherapy in PD-L1 ≥ 50% NSCLC: a Biomarker Guided Phase 2 Trial - HYPERBOLIC Trial
- ClinicalTrials.gov ID
- NCT07274384
- Acronym / sponsor ID
- HYPERBOLIC / 2025-521583-35-00
- Keywords
- lung, cancer, hyperprogression, chemotherapy, immunotherapy, carboplatin, cisplatin, pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 10 Dec 2025 (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.
In metastatic NSCLC patients with PD-L1 expression ≥50%, a circulating immature (CD10-) LDNs level of ≥30.5% confers a high risk of hyperprogression (HPD) with first line single-agent immune-checkpoint inhibitors (SA-ICI). HPD is defined as a tumor growth rate (TGR) delta ≥50% between pre-treatment and post-treatment, and/or a TGR ratio ≥2. The combination of platinum-based chemotherapy (PCT) with ICI in this setting could prevent the occurrence of HPD and ultimately improve survival outcomes.
This randomized, multicentric, open-label, phase 2 trial will include patients with stage IV NSCL, without targetable oncogene drivers, PD-L1 TPS≥50%, and measurable disease on two CT scans performed before randomization. Participants will be randomized 1:1 to SA-ICI or ICI+PCT. Radiological evaluation will be performed by CT-scan at 6-8 weeks and subsequently according to the local investigators' schedule.
In the SA-ICI arm, ICI regimen will include cemiplimab. In the PCT+ICI arm, PCT regimens will include both carboplatin or cisplatin + pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab.
PCT will be administered for three cycles. In case of stable disease or partial response according to RECIST v.1.1, cemiplimab will be performed as monotherapy from the third cycle until disease progression or unacceptable toxicity. If progression according to RECIST v.1.1 or HPD after three cycles of PCT+ICI, patients will be treated with standard second line therapy as local standard of care.
Detailed description
Intervention: PCT plus cemiplimab for 3 cycles followed by cemiplimab in case of absence of PD/HPD. PCT regimens will include both carboplatin (area under the concentration-time curve, 5 mg per milliliter per minute) or cisplatin (75 mg per square meter of body surface area) plus pemetrexed (500 mg per square meter) for non-squamous histology or paclitaxel (200 mg per square meter) for squamous histology. All drugs in the PCT regimens will be administered intravenously every 3 weeks. Cemiplimab 350 mg "flat dose" will be administered intravenously every 3 weeks. Treatment will continue for a maximum of 108 weeks or until progression or unacceptable toxicity.
Comparator: Single-agent cemiplimab. Cemiplimab 350 mg "flat dose" will be administered intravenously every 3 weeks for 108 weeks or until progression or unacceptable toxicity.
Efficacy criteria: The rate of patients experienced HPD or ED will be calculated for both treatment arms.1 HPD is defined as a delta of tumor growth rate (TGR) ≥50% and/or a TGR ratio ≥2. TGR will be computed using RECIST v.1.1 on three consecutive, centrally revised, CT scans (two CT scans before treatment start and one after 7 week ± 5 days from treatment start).
Central review of CT scans will be performed before treatment start and after the first radiological evaluation (before third cycle). RECIST response after the second cycles will be decided according to central review.
ED is defined as tumor-related death within 12 weeks from ICI initiation, in absence of a radiological evaluation performed during ICI.
HPD rate according to definitions proposed by Lo Russo et al., Matos et al.et Saâd-Bouzid et al., will be evaluated as a secondary endpoint.
Efficacy parameters: After the first radiological evaluation performed at 7 weeks ± 5 days from treatment start, subjects will be evaluated by CT scans every 12 weeks ± 28 days according to local investigators' schedule.
CT scans are to be performed until disease progression or until the start of new anticancer treatment, withdrawal of consent, or death, whichever occurs first.
Per RECIST 1.1, the partial and complete response should be confirmed by a repeat tumor imaging assessment not less than 4 weeks from the date the response was first documented.
The enrollment period will last 48 months. The approximate duration of the active study assessments for each patient, including the screening phase, will be 3 months (the time required to confirm HPD occurrence or not). The duration of the active portion of the study will be 48 months, followed by and additional 3 months of follow-up, for a total of 51 months. In both arms, patients will receive treatment for a maximum of 108 weeks or until disease progression or unacceptable toxicity occurs. After the active portion of the study is completed, all patients will be followed for survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, open-label
| Arm | Type | Receives |
|---|---|---|
| single-agent immune-checkpoint inhibitors | Active comparator | Drug: Cemiplimabsingle-agent immune-checkpoint inhibitors (SA-ICI) (Cemiplimab) |
| PCT regimens + immune-checkpoint inhibitors | Experimental | Combination Product: chemotherapy plus cemiplimabPCT regimens will include both carboplatin or cisplatin plus pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- The participant (or legally acceptable representative) has provided documented informed consent to participation to the study and data protection consent form.
- Male or female aged 18 years or older.
- ECOG Performance Status of 0 - 2.
- Pathologically (histologically or cytologically) confirmed diagnosis of stage IV NSCLC (TNM 8th edition), who received no prior systemic treatment for recurrent or metastatic NSCLC. Mixed squamous/non-squamous tumors are eligible.
- PD-L1 TPS ≥ 50% (by local test).
Key exclusion criteria (11 listed)
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication
- Known uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent). No serological testing is required unless mandated by local health authority.
- Administration of live or live-attenuated vaccines within 30 days before the baseline LDNs assessment. Administration of killed vaccines is allowed. Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
- Administration of radiotherapy within 7 days prior to the baseline LDNs assessment.
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 |
|---|---|---|
| chemotherapy plus cemiplimabAlso: cemiplimab, carboplatin, cisplatin, pemetrexedCombination of platinum-based chemotherapy (PCT) with ICI. PCT regimens will include both carboplatin or cisplatin plus pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab. PCT will be administered for three cycles. | Combination product | PCT regimens + immune-checkpoint inhibitors |
| CemiplimabAlso: libtayosingle-agent immune-checkpoint inhibitors | Drug | single-agent immune-checkpoint inhibitors |
Primary outcome
HPD rate
Time frame: up to HPD, end of treatment for a maximum of 108 weeks whichever comes first
HPD rate, defined as the proportion of patients with a delta of TGR ≥50% or a TGR ratio ≥2 at 7 weeks ± 5 days from randomization
ED rate
Time frame: up to ED, end of treatment for a maximum of 108 weeks whichever comes first
ED rate: who died without undergoing a scan after treatment initiation.
4 secondary outcomes
Overall survival (OS)
Time frame: up to HPD, ED, end of treatment for a maximum of 108 weeks whichever comes first
Progression free survival (PFS)
Time frame: up to HPD, ED, end of treatment for a maximum of 108 weeks whichever comes first
Objective response rate (ORR)
Time frame: up to HPD, ED, end of treatment for a maximum of 108 weeks whichever comes first
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 90 days after the last dose of study 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 10 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy plus cemiplimab and Cemiplimab in people with NSCLC (Non-small Cell Lung Cancer) and Hyperprogression, run by Università Vita-Salute San Raffaele.
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 22 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
HPD rate (time frame: up to HPD, end of treatment for a maximum of 108 weeks whichever comes first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.