Non-small Cell Lung CancerPhase 3NCT06254599

A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

A Phase 3 study testing SY-3505 Capsules and Crizotinib Capsules in people with Non-small Cell Lung Cancer, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: SY-3505 Capsules and Crizotinib Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 1 siteChina
Study dates: 1 May 2024to 1 May 2027
Phase: Phase 3
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

At the time of signing the informed consent form (ICF), age is ≥ 18 years.
Histologically or cytologically diagnosed with stage IV or stage IIIB and IIIC NSCLC that cannot be cured by surgery or radiotherapy (as per the 8th edition of the International Association for the Study of Lung Cancer [IASLC] Lung Cancer Staging).
No prior systemic anti-tumor therapy for NSCLC, including but not limited to systemic chemotherapy, ALK-TKI, immunotherapy, and biologic therapy, etc. [1. Patients assessed by the investigator as not having received "adequate" systemic anti-tumor therapy (such as having received up to 1 prior chemotherapy regimen, etc.), and 2. Patients who have received neoadjuvant or adjuvant therapy, with the last treatment at least 6 months before randomization, are allowed to be included].
The tumor tissue or blood sample of the patient meets one of the following two criteria: a. Previously confirmed by a local laboratory as ALK fusion-positive (patients included based on previously confirmed ALK fusion-positive test results should provide tumor tissue [available archived samples or fresh biopsy samples] that meets the requirements as much as possible after signing the ICF and before the first dose for central laboratory ALK fusion positive reconfirmation based on study progression needs). b. In the absence of a previous ALK fusion positive test report, a tumor tissue (available archived samples or fresh biopsy samples) or blood sample meeting the requirements must be provided, and the sample is confirmed as ALK fusion positive in the designated center laboratory by the sponsor.
At least one extra-cranial target lesion that meets the RECIST v 1.1 criteria definition; for lesions previously treated with radiotherapy, only when the lesion shows clear progression after radiotherapy can it be considered a target lesion.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2.

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Expected survival time of ≥ 3 months.
Before the first dose, the adverse events (AEs) related to previous anti-tumor therapy have recovered to Grade ≤ 1 as defined by NCI-CTCAE v 5.0 (excluding toxicities judged by the investigator to have no safety risks, such as alopecia, Grade 2 peripheral neuropathy related to previous platinum-based treatment, etc.).
Organ function levels must meet the following requirements (supportive treatment that affects the following results has not been received within 7 days before the test):
Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.0×10^9/L, platelets (PLT) ≥ 75×10^9/L, hemoglobin (Hb) ≥ 90g/L;
Liver function: In the absence of liver metastasis, serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5× the upper limit of normal (ULN), and serum total bilirubin (TBIL) ≤ 1.5× ULN; with liver metastasis, AST and ALT both ≤ 5.0× ULN, and TBIL ≤ 3× ULN;
Renal function: Creatinine clearance rate (Ccr) ≥ 50 mL/min (according to the Cockcroft and Gault formula);
Coagulation function: International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5× ULN (except for patients receiving anticoagulant therapy).
Able to swallow pills and able to comply with the visits and related procedures as specified in the protocol.
Fertile subjects agree to use effective contraceptive measures during the entire study period and for at least 3 months after the last dose

Who cannot join

Patients who meet any of the following criteria are not eligible to participate in this study:
Carrying known major driver gene mutations other than ALK, such as EGFR, MET, RET, ROS1, NTRK, etc. (patients with co-mutations can discuss with the investigator whether they can be included).
History of allergy to any component or excipient of SY-3505 capsules or crizotinib capsules.
Concurrent primary malignancies, with the following exceptions: cured and not relapsed malignant tumors within 2 years before screening, and cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
Presence of symptomatic primary central nervous system (CNS) tumors, symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Exception: Patients with stable CNS conditions (no evidence of progression on imaging examinations for at least 4 weeks before the first dose and all neurological symptoms have returned to baseline), no evidence of new or enlarged brain metastases, no CNS surgery or radiotherapy within 4 weeks before the first dose, no stereotactic radiosurgery (SRS) within 2 weeks, and discontinuation or stable dose of steroids within 2 weeks (this exception does not include carcinomatous meningitis, which should be excluded regardless of its clinical status).
Concomitant symptoms or diseases before the first dose that are poorly controlled even after optimal treatment (chronic diseases do not require screening):

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Uncontrolled active systemic bacterial, viral, or fungal infections;
Pleural effusion, ascites, or pericardial effusion poorly controlled after intervention (poorly controlled indicates significant increase in effusion within 2 weeks after drainage, with significant symptoms requiring re-puncture or other interventions);
Poorly controlled diabetes (fasting blood glucose ≥ 11.1mmol/L and/or HbA1c ≥ 8%);
Symptomatic hyperthyroidism or hypothyroidism that is not controlled according to the investigator's assessment;
Clinically significant electrolyte disturbances evaluated by the investigator (such as hypocalcemia, hypomagnesemia, or hypokalemia);
Clinically significant active gastrointestinal diseases, including active ulcerative colitis, Crohn's disease, gastrointestinal ulcers, or previous surgical procedures that may significantly affect drug absorption.
Presence of severe cardiovascular diseases/abnormalities, meeting any of the following:
Fridericia-corrected QT interval (QTcF) > 470 msec (females) or 450 msec (males) during screening (if QTcF prolongation suspected to be drug-induced is assessed as safe and controllable by the investigator, the patient can be included after correction with medication);
Left ventricular ejection fraction (LVEF) < 50%;
Myocardial infarction or unstable angina within 6 months before the first dose or clinically significant uncontrolled arrhythmias, including bradycardias that may lead to QTcF prolongation (such as type II second-degree or third-degree atrioventricular block);
Classified as New York Heart Association (NYHA) class III or IV congestive heart failure;
Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg), history of unstable hypertension, or poor compliance with antihypertensive treatment.
Active viral infections or history of the following:
Hepatitis B during screening (positive results for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb] with HBV-DNA ≥2×103 IU/mL; patients whose HBV-DNA levels drop to below 2×103 IU/mL after regular antiviral treatment can be included), or active hepatitis C (HCV RNA > central detection upper limit of normal [ULN]);
Human immunodeficiency virus (HIV) positive during screening, or known history of other immunodeficiency diseases, or receiving long-term systemic corticosteroid therapy (daily dose of prednisone exceeding 10 mg or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose;
History of organ transplantation, hematopoietic stem cell, or bone marrow transplantation.
Other lung diseases requiring systemic treatment or severe lung diseases, such as active pulmonary tuberculosis, interstitial lung disease, etc., which, in the investigator's judgment, may affect the interpretation of the study results or put the patient at high risk.
Use of or inability to stop using the following CYP3A4 potent inhibitors or inducers within 2 weeks before the first dose during the study. CYP3A4 potent inhibitors: Atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit (juice); CYP3A4 potent inducers: Carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort, rifabutin.
Underwent radiotherapy within 2 weeks before the first dose or experienced radiation-related toxicities requiring corticosteroid therapy.
Used Chinese herbal medicine or preparations with indications for anti-tumor therapy or tumor adjuvant therapy within 2 weeks before the first dose.
Underwent major surgery within 4 weeks before the first dose (major surgery defined as surgery with a grade ≥3, excluding central venous catheter placement, tumor biopsy, and gastric tube insertion) or experienced significant trauma and has not fully recovered.
Participated in other clinical trials within 4 weeks before the first dose (Note: Except for those who did not use investigational drugs or investigational medical devices; those who stopped treatment in other clinical trials and only underwent follow-up for survival period).
Received lung radiotherapy >30 Gy within 6 months before the first dose.
Experienced severe arterial/venous thrombotic events within 1 year before the first dose (such as cerebrovascular accident [including transient ischemic attack], deep vein thrombosis, pulmonary embolism) and judged by the investigator as not suitable for participation in this trial, or has a significant bleeding tendency within 30 days before the first dose, or judged by the investigator to have a risk of significant gastrointestinal bleeding, etc.
Pregnancy (screening pregnancy test result for women of childbearing age must be negative) or breastfeeding women.
Other situations deemed unsuitable for participation in this clinical trial by the investigator, such as other severe acute or chronic diseases that may increase the patient's related risks in the study or laboratory abnormalities that may interfere with the interpretation of the study results.

Trial locations and contacts

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

Yinghui Sun contact

86-10-88858616

yhsun@centaurusbio.com

China1 site

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Yuankai Shi, MD, 86-10-87788293, syuankai@cicams.ac.cn

Other trials in China

About this study

Official title: A Phase III Study to Evaluate and Compare the Efficacy and Safety of SY-3505 Versus Crizotinib in Treatment-Naive Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer

A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.

Read the detailed description

This is a multicenter, randomized controlled phase III trial to evaluate the efficacy and safety of SY-3505 capsule vs. crizotinib capsule in treatment-naive patients with ALK-positive NSCLC.

Participants will be randomized in a 2:1 ratio to receive SY-3505, 600 milligrams (mg) orally once daily (QD), or crizotinib, 250 mg orally twice daily (BID). Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Conditions: Non-small Cell Lung Cancer
Being tested: SY-3505 Capsules, Crizotinib Capsules
Keywords: SY-3505, Anaplastic lymphoma kinase, Non-small Cell Lung Cancer, Third-generation ALK tyrosine kinase inhibitor
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.

SY-3505 CapsulesDrug
Also called CT-3505; Ficonalkib
A third-generation ALK tyrosine kinase inhibitor
Crizotinib CapsulesDrug
Also called Xalkori
An oral ALK tyrosine kinase inhibitor

Study groups in NCT06254599
Study group	Role	What they receive
SY-3505	Experimental	SY-3505, single agent, 600 mg oral capsules, QD, continuously Receives: Drug: SY-3505 Capsules
Crizotinib	Active comparator	Crizotinib, single agent, 250 mg oral capsules, BID, continuously Receives: Drug: Crizotinib Capsules

What is being measured

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

Progression-free survival (PFS) assessed by independent radiology review (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria.
PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first.
Measured: Up to 2 years

Secondary outcomes (8)

Progression-free survival (PFS) assessed by investigator based on RECIST v1.1 criteria.
PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first.
Measured: Up to 2 years
Objective Response Rate (ORR) assessed by IRC and investigator
ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per IRC and investigator based on RECIST v1.1 after the initiation of study treatment.
Measured: Up to 2 years
Disease Control Rate (DCR) assessed by IRC and investigator
DCR is defined the percentage of the participants who have achieved an objective response (CR or PR) or stable disease (SD) per IRC and investigator based on RECIST v1.1 after the initiation of study treatment.
Measured: Up to 2 years
Duration of Response (DoR) assessed by IRC and investigator
DoR is defined as the time from the first occurrence of an objective response (CR or PR), based on RECIST v1.1 to first documented disease progression or death.
Measured: Up to 2 years
Intracranial Objective Response Rate (IC-ORR) assessed by IRC and investigator
IC-ORR is defined as the proportion of patients with intracranial target lesions that are measurable at baseline who achieve an objective response (CR or PR) according to RECIST 1.1 and Revised Assessment in Neuro Oncology (RANO) criteria.
Measured: Up to 2 years
Intracranial Disease Control Rate (IC-DCR) assessed by IRC and investigator
IC-DCR is defined as the proportion of patients with intracranial target lesions that are measurable at baseline who achieve an objective response (CR or PR) or SD according to RECIST 1.1 and Revised Assessment in Neuro Oncology (RANO) criteria.
Measured: Up to 2 years
Intracranial Duration of Response (IC-DoR) assessed by IRC and investigator
IC-DoR was defined as time from documentation of intracranial response (CR or PR) to intracranial disease progression or death.
Measured: Up to 2 years
Overall Survival (OS)
OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. It will be censored on the date of last contact for those participants who are alive.
Measured: Up to 2 years

Timeline

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

1 May 20241 May 2027

First posted12 Feb 2024
Study start1 May 2024 (estimated)
Primary completion1 May 2026 (estimated)
Study completion1 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung CancerStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 255 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06254599
Sponsor's protocol ID: CT-3505-III-01
Status last verified: Feb 2024
First submitted: 1 Feb 2024
Last updated: 12 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Study to Evaluate and Compare the Efficacy and Safety of SY-3505 Versus Crizotinib in Treatment-Naive Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06254599
Acronym / sponsor ID: CT-3505-III-01
Conditions: Non-small Cell Lung Cancer
Keywords: SY-3505, Anaplastic lymphoma kinase, Non-small Cell Lung Cancer, Third-generation ALK tyrosine kinase inhibitor
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 255 participants (estimated)
Lead sponsor: Shouyao Holdings (Beijing) Co. LTDUniversity, hospital or other
Study start: 1 May 2024 (estimated)
Primary completion: 1 May 2026 (estimated)
Study completion: 1 May 2027 (estimated)
First posted: 12 Feb 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.

A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.

Detailed description

This is a multicenter, randomized controlled phase III trial to evaluate the efficacy and safety of SY-3505 capsule vs. crizotinib capsule in treatment-naive patients with ALK-positive NSCLC.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SY-3505	Experimental	Drug: SY-3505 CapsulesSY-3505, single agent, 600 mg oral capsules, QD, continuously
Crizotinib	Active comparator	Drug: Crizotinib CapsulesCrizotinib, single agent, 250 mg oral capsules, BID, continuously

Who may qualify

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

Key inclusion criteria (15 listed)

At the time of signing the informed consent form (ICF), age is ≥ 18 years.
Histologically or cytologically diagnosed with stage IV or stage IIIB and IIIC NSCLC that cannot be cured by surgery or radiotherapy (as per the 8th edition of the International Association for the Study of Lung Cancer [IASLC] Lung Cancer Staging).
No prior systemic anti-tumor therapy for NSCLC, including but not limited to systemic chemotherapy, ALK-TKI, immunotherapy, and biologic therapy, etc. [1. Patients assessed by the investigator as not having received "adequate" systemic anti-tumor therapy (such as having received up to 1 prior chemotherapy regimen, etc.), and 2. Patients who have received neoadjuvant or adjuvant therapy, with the last treatment at least 6 months before randomization, are allowed to be included].
The tumor tissue or blood sample of the patient meets one of the following two criteria: a. Previously confirmed by a local laboratory as ALK fusion-positive (patients included based on previously confirmed ALK fusion-positive test results should provide tumor tissue [available archived samples or fresh biopsy samples] that meets the requirements as much as possible after signing the ICF and before the first dose for central laboratory ALK fusion positive reconfirmation based on study progression needs). b. In the absence of a previous ALK fusion positive test report, a tumor tissue (available archived samples or fresh biopsy samples) or blood sample meeting the requirements must be provided, and the sample is confirmed as ALK fusion positive in the designated center laboratory by the sponsor.
At least one extra-cranial target lesion that meets the RECIST v 1.1 criteria definition; for lesions previously treated with radiotherapy, only when the lesion shows clear progression after radiotherapy can it be considered a target lesion.

Key exclusion criteria (32 listed)

Patients who meet any of the following criteria are not eligible to participate in this study:
Carrying known major driver gene mutations other than ALK, such as EGFR, MET, RET, ROS1, NTRK, etc. (patients with co-mutations can discuss with the investigator whether they can be included).
History of allergy to any component or excipient of SY-3505 capsules or crizotinib capsules.
Concurrent primary malignancies, with the following exceptions: cured and not relapsed malignant tumors within 2 years before screening, and cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
Presence of symptomatic primary central nervous system (CNS) tumors, symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Exception: Patients with stable CNS conditions (no evidence of progression on imaging examinations for at least 4 weeks before the first dose and all neurological symptoms have returned to baseline), no evidence of new or enlarged brain metastases, no CNS surgery or radiotherapy within 4 weeks before the first dose, no stereotactic radiosurgery (SRS) within 2 weeks, and discontinuation or stable dose of steroids within 2 weeks (this exception does not include carcinomatous meningitis, which should be excluded regardless of its clinical status).

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
SY-3505 CapsulesAlso: CT-3505; FiconalkibA third-generation ALK tyrosine kinase inhibitor	Drug	SY-3505
Crizotinib CapsulesAlso: XalkoriAn oral ALK tyrosine kinase inhibitor	Drug	Crizotinib

Primary outcome

Progression-free survival (PFS) assessed by independent radiology review (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria.
Time frame: Up to 2 years
PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first.

8 secondary outcomes

Progression-free survival (PFS) assessed by investigator based on RECIST v1.1 criteria.
Time frame: Up to 2 years
Objective Response Rate (ORR) assessed by IRC and investigator
Time frame: Up to 2 years
Disease Control Rate (DCR) assessed by IRC and investigator
Time frame: Up to 2 years
Duration of Response (DoR) assessed by IRC and investigator
Time frame: Up to 2 years
Intracranial Objective Response Rate (IC-ORR) assessed by IRC and investigator
Time frame: Up to 2 years
Intracranial Disease Control Rate (IC-DCR) assessed by IRC and investigator
Time frame: Up to 2 years
Intracranial Duration of Response (IC-DoR) assessed by IRC and investigator
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.

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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.

Yinghui Sun contact

86-10-88858616

yhsun@centaurusbio.com

Yinghui Sun study director

Shouyao Holdings (Beijing) Co. LTD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SY-3505 Capsules and Crizotinib Capsules in people with Non-small Cell Lung Cancer, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Yinghui Sun (86-10-88858616, yhsun@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by independent radiology review (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06254599.

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 12 Feb 2024.