Non-small Cell Lung CancerPhase 2PHOEBSNCT04967417
Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive NSCLC Patients With Asymptomatic Brain Metastases
A Phase 2 study testing Pemetrexed, Carboplatin, Pembrolizumab and Paclitaxel, Carboplatin, Pembrolizumab in people with Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases. This study will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pemetrexed, Carboplatin, Pembrolizumab and Paclitaxel, Carboplatin, Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2022to 2 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female participants who are at least 19 years of age on the day of signing informed consent with histologically confirmed diagnosis of stage IV non-small cell lung cancer with brain metastases will be enrolled in this study.
- Must have at least one intracranial target lesion. Intracranial lesion must be equal or greater than the 10mm in longest diameter.
- Have confirmation that EGFR or ALK-directed therapy is not indicated
- Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Otherwise, previously treated with radiation is not considered as measurable lesion.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
- Have a life expectancy of at least 3 months
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- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Have adequate organ function
- Male participants: A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
- b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to IP administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents prior to IP administration as a metastatic disease treatment, including tyrosine kinase inhibitor.
- Had major surgery < 3 weeks prior to first dose
- No measurable CNS lesion other than CNS lesion treated with stereotactic radiotherapy or surgery
- Had received whole brain radiotherapy or stereotactic radiotherapy to CNS disease.
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- Has received prior radiotherapy within 1 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-CNS disease.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid cancer or early gastric cancer or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has known active carcinomatous meningitis.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis that currently required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has a active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive with HBV DNA positive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. These patients can be participated with appropriate treatment and prophylactic treatment based on the investigator's decision.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive Non-small Cell Lung Cancer Patients With Asymptomatic Brain Metastases
This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases.
This study will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes.
Read the detailed description
This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases. Patients will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes. After the 4 cycles of combination phase with cytotoxic chemotherapy, maintenance phase will be followed for maximum of 35 cycles. If the disease progression is observed in CNS only which can be controlled with local treatment, systemic treatment can be continued as beyond disease progression.
Non-squamous cell carcinoma:
4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Squamous cell carcinoma:
4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Pemetrexed, Carboplatin, Pembrolizumab, Paclitaxel, Carboplatin, Pembrolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed, Carboplatin, PembrolizumabDrug
Also called Alimta, Preizer carboplatin, keytruda
- Pemetrexed 500mg/m2
- Carboplatin AUC 5.0
- Pembrolizumab 200mg
Paclitaxel, Carboplatin, PembrolizumabDrug
Also called Anzatax, Preizer carboplatin, keytruda
- Paclitaxel 200mg/m2
- Caboplatin AUC 6.0
- Pembrolizumab 200mg
| Study group | Role | What they receive |
|---|---|---|
| Non-squamous cell carcinoma | Experimental | * 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks
* Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles Receives: Drug: Pemetrexed, Carboplatin, Pembrolizumab |
| Squamous cell carcinoma | Experimental | * 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks
* Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles Receives: Drug: Paclitaxel, Carboplatin, Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Objective Response Rate
Intracranial objective response is defined as the investigator's best non-confirmed response as CR (complete response) or PR (partial response) as determined using RECIST v1.1. Subjects who do not meet these criteria, including those without a post-baseline tumor assessment, are considered non-responders. Intracranial objective response rate (iORR) is defined as the proportion of subjects who achieved an objective response among all subjects treated with the IP who had measurable disease at baseline.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of t the diameters of target lesion.
Measured: Up to 24 months
Secondary outcomes (6)
Progression Free Survival (PFS)
PFS is defined as the period between the start date of the investigational drug and the date of the first documented disease progression or death, whichever occurs first.
- PFS (month) = (date of the first documented disease progression or death - date of the start of the investigational drug + 1) / 30.4375
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum of diameters (nadir) on study (this includes the baseline sum if that is the smallest on study), or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: The time until the date of either disease progression or the all-cause mortality from the date of IP administration. Up to 30 months
Overall Survival (OS)
Overall survival defined by date of all-cause mortality from the date of IP Administration will be calculated.
Measured: The time until defined by date of all-cause mortality from the date of IP Administration. Up to 30 months.
Intracranial Duration of Response
The duration for intracranial response will be calculated separately to evaluate the intracranial efficacy of IP drug
Measured: Up to 30 months.
Intracranial Progression-free Survival
Progression free survival of intracranial disease defined by the date of disease progression of intracranial lesion from the date of IP administration will be calculated.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum of diameters (nadir) on study (this includes the baseline sum if that is the smallest on study), or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Up to 30 months.
Objective Response Rate
Objective response rate is defined as the investigator's best non-confirmed response as CR (complete response) or PR (partial response) as determined using RECIST v1.1. Subjects who do not meet these criteria, including those without a post-baseline tumor assessment, are considered non-responders. objective response rate (ORR) is defined as the proportion of subjects who achieved an objective response among all subjects treated with the IP who had measurable disease at baseline.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of t the diameters of target lesion.
Measured: Up to 30 months.
Adverse Events
Adverse event will be evaluated using CTCAE v5.0
Measured: from the date of informed consent signature to 30 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start26 May 2022
- Primary completion30 Jun 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-squamous cell carcinoma: 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles Squamous cell carcinoma: 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Ju Ahn, Samsung Medical Center
- Investigators
- Myung-Ju Ahn, MD, phD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967417
- Sponsor's protocol ID
- 2021-06-008
- Acronym
- PHOEBS
- Status last verified
- May 2025
- First submitted
- 29 Jun 2021
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive Non-small Cell Lung Cancer Patients With Asymptomatic Brain Metastases
- ClinicalTrials.gov ID
- NCT04967417
- Acronym / sponsor ID
- PHOEBS / 2021-06-008
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases.
This study will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes.
Detailed description
This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases. Patients will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes. After the 4 cycles of combination phase with cytotoxic chemotherapy, maintenance phase will be followed for maximum of 35 cycles. If the disease progression is observed in CNS only which can be controlled with local treatment, systemic treatment can be continued as beyond disease progression.
Non-squamous cell carcinoma:
4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
Squamous cell carcinoma:
4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-squamous cell carcinoma: 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles Squamous cell carcinoma: 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles
| Arm | Type | Receives |
|---|---|---|
| Non-squamous cell carcinoma | Experimental | Drug: Pemetrexed, Carboplatin, Pembrolizumab* 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks * Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles |
| Squamous cell carcinoma | Experimental | Drug: Paclitaxel, Carboplatin, Pembrolizumab* 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks * Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male/female participants who are at least 19 years of age on the day of signing informed consent with histologically confirmed diagnosis of stage IV non-small cell lung cancer with brain metastases will be enrolled in this study.
- Must have at least one intracranial target lesion. Intracranial lesion must be equal or greater than the 10mm in longest diameter.
- Have confirmation that EGFR or ALK-directed therapy is not indicated
- Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Otherwise, previously treated with radiation is not considered as measurable lesion.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
Key exclusion criteria (22 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to IP administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents prior to IP administration as a metastatic disease treatment, including tyrosine kinase inhibitor.
- Had major surgery < 3 weeks prior to first dose
- No measurable CNS lesion other than CNS lesion treated with stereotactic radiotherapy or surgery
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 |
|---|---|---|
| Pemetrexed, Carboplatin, PembrolizumabAlso: Alimta, Preizer carboplatin, keytruda* Pemetrexed 500mg/m2 * Carboplatin AUC 5.0 * Pembrolizumab 200mg | Drug | Non-squamous cell carcinoma |
| Paclitaxel, Carboplatin, PembrolizumabAlso: Anzatax, Preizer carboplatin, keytruda* Paclitaxel 200mg/m2 * Caboplatin AUC 6.0 * Pembrolizumab 200mg | Drug | Squamous cell carcinoma |
Primary outcome
Intracranial Objective Response Rate
Time frame: Up to 24 months
Intracranial objective response is defined as the investigator's best non-confirmed response as CR (complete response) or PR (partial response) as determined using RECIST v1.1. Subjects who do not meet these criteria, including those without a post-baseline tumor assessment, are considered non-responders. Intracranial objective response rate (iORR) is defined as the proportion of subjects who achieved an objective response among all subjects treated with the IP who had measurable disease at baseline. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of t the diameters of target lesion.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: The time until the date of either disease progression or the all-cause mortality from the date of IP administration. Up to 30 months
Overall Survival (OS)
Time frame: The time until defined by date of all-cause mortality from the date of IP Administration. Up to 30 months.
Intracranial Duration of Response
Time frame: Up to 30 months.
Intracranial Progression-free Survival
Time frame: Up to 30 months.
Objective Response Rate
Time frame: Up to 30 months.
Adverse Events
Time frame: from the date of informed consent signature to 30 days after last drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung-Ju Ahn, MD, phD principal investigator
Samsung Medical Center
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 Pemetrexed, Carboplatin, Pembrolizumab and Paclitaxel, Carboplatin, Pembrolizumab in people with Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 22 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: finished, as of the sponsor's last update on 9 May 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intracranial Objective Response Rate (time frame: Up to 24 months). 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 9 May 2025.