Lung NeoplasmsPhase 2NCT05326425
Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
A Phase 2 study testing lazertinib(YH25448) in people with Lung Neoplasms, run by Jin Hyoung Kang at 6 sites in South Korea.
Trial summary
This is an open-label, single-intervention, multicenter clinical trial in patients with non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after failure of EGFR TKI treatment. The objective of this study is as follows. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- lazertinib(YH25448)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 23 Jun 2021to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily provided written informed consent prior to participation in the clinical trial and genetics and/or exploratory studies
- Male or female, 20 years of age or older(Female patients must agree to the use of appropriate contraceptive methods and not be lactating, and for women of childbearing age, there must be evidence that the pregnancy test is negative prior to initiation of dosing)
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer patients. This may occur as systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/C or IV disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, with no deterioration in the last 2 weeks
- Life expectancy judged by the Investigator of at least 3 months
- Asymptomatic or mild symptomatic brain metastases progressed or newly confirmed patients
Show all 10Show fewer
- For one or more intracranial measurable disease, the maximum baseline diameter is measured to be 10mm or more on CT or MRI, and this lesions can be ccurately measured. (The target lesion that has received previous local therapy should not be considered as measurable. However, new CNS lesion after more than 3 months of previous local therapy could be considered as target lesion. )
- Confirmed sensitizing EGFR mutation prior to administration of gefitinib, erlotinib, or afatinib (L858R, Exon 19 deletion, G719X and L861Q mutations chould be confirmed as a record)
- Failure after one regimen of EGFR TKI treatment. Past treatment history for locally advanced or metastatic NSCLC limited to one regimen of EGFR TKI treatment (gefitinib, erlotinib, or afatinib) and/or one palliative cytotoxic chemotherapy regimen.
- Those who have been confirmed status of T790M mutations in tissues or blood after EGFR TKI failure (T790M positive or negative should be confirmed as a record)
Who cannot join
- Prior treatment with lazertinib
- Prior treatment with investigational drugs in other clinical trials within 30 days prior to the first administration
- Patients who received cytotoxic chemotherapy for the treatment of advanced non-small cell lung cancer or other anticancer drugs other than EGFR TKI within 14 days prior to the first administration of the investigational drug
- Prior local-regional therapy within 4 weeks prior to Day 1 of trial treatment (e.g., major surgery, radiation therapy [with the exception of palliative bone-directed radiotherapy and radiotherapy administered to superficial lesions], hepatic arterial embolization, transcatheter arterial chemoembolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
- Patients currently receiving drugs or herbal supplements known as inhibitors or inducers of CYP3A4 or who cannot discontinue use at least 1 week prior to the first dose of lazertinib.
- Previous anticancer treatment-related toxicities not recovered to baseline or Grade 0-1 (except alopecia)
Show all 19Show fewer
- Symptomatic spinal cord compression (However, registration is allowed if steroid treatment is not required within at least 2 weeks before the start of administration of the investigational drug)
- Symptomatic and unstable central nervous system (CNS) or brain metastasis requiring local treatment at screening. (Asymptomatic or mild symptomatic leptomeningeal metastasis is also permitted to be registered)
- Symptomatic or intracranial bleeding that needs treatment
- History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Carcinoma other than non-small cell lung cancer, if the investigator is judged to be inadequate to participate in this clinical trial due to evidence of severe or uncontrolled systemic disease, uncontrolled hypertension, or active bleeding tendency, or that it is difficult to follow this protocol. (Screening for chronic disease is not required)
- Any of the following cardiovascular diaseases: A history of congestive heart failure (CHF) of grade 3 or higher according to the New York Heart Association Classification (NYHA) or cardiac arrhythmia requiring treatment/A History of unstable angina or myocardial infarction experienced within 6 months before the first administration of the investigational drug/Left ventricular ejection fraction <50% on recent echocardiography or MUGA scan
- Known human immunodeficiency virus (HIV) infection
- Patient has known active hepatitis B virus(HBV) or hepatitis C virus (HCV) infection
- Patients with refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow the product, or undergoing enterectomy deemed to interfere with the proper absorption of lazertinib.
- History of hypersensitivity to drugs
- Clinically significant chronic infection or major medical or mental illness
- Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the study at the discretion of the Investigators
- History of allogeneic hematopoietic stem cell transplantation, history of whole blood transfusions that did not remove leukocytes within 120 days before the date of collection of genetics specimens
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do
Yu Jung Kim, 82-10-5265-9503, cong1005@gmail.com
Yu Jung Kim
- Recruiting
Gachon University Gil Medical Center
Incheon
Hee Kyung Ahn, 82-10-9933-5099, hkahn.onco@gmail.com
- Recruiting
Korea University Anam Hospital
Seoul
Ju Won Kim, 82-10-6254-5546, kohyot35@gmail.com
YoonJi Choi, 82-10-8964-6724, yj_choi@korea.ac.kr
- Recruiting
Seoul National University Hospital
Seoul
Bhumsuk Keam, 82-10-3231-2208, bhumsuk@snu.ac.kr
Bhumsuk Keam
- Recruiting
Seoul St. Mary's Hospital, Catholic University of Korea
Seoul
JIN HYOUNG KANG, 82-2-2258-6043, oncologykang@naver.com
SoHee Park, 82-2-2258-6546, vicky3018@naver.com
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Hye Ryun Kim, 82-10-8713-4793, nobelg@yuhs.ac
Hye Ryun Kim
About this study
Official title: Lazertinib in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Metastatic Non-Small Cell Lung Cancer With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR Tyrosine Kinase Inhibitor
This is an open-label, single-intervention, multicenter clinical trial in patients with non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after failure of EGFR TKI treatment. The objective of this study is as follows.
- Primary objective : intracranial objective response rate (iORR) with RECIST 1.1
- Secondary objectives : intracranial progression free survival(iPFS), Intracranial objective response rate in T790M negative, isolated CNS progression patient group, overall Objective Rsponse Rate(ORR), duration of response(DoR), disease control rate(DCR), treatment failure pattern): intracranial progression or extracranial progression or both, salvage intracranial treatment rate, safety and tolerability
Read the detailed description
Patients who eligible the inclusion/exclusion criteria should take lazertinib 240 mg (80 mg, 3 tablets) once a day at the same time as possible on an empty stomach before meals. One cycle of treatment is defined as 42 days of continuous administration, and the tumor response by RECIST 1.1 will be evaluated every 1 cycle for the 1st, 2nd, 3rd, and 4th evaluation, and every 2 cycles from the 5th evaluation thereafter. .
If the investigator decides to reduce the dose due to an adverse drug reaction during the administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of lazertinib.
Efficacy and safety will be evaluated by administering lazertinib 240 mg to patients with measurable brain metastasis or newly confirmed metastatic non-small cell lung cancer after failure of treatment with gefitinib, erlotinib, or afatinib after EGFR mutation is confirmed.
- Conditions
- Lung Neoplasms
- Being tested
- lazertinib(YH25448)
- Keywords
- NSCLC, Brain Metastases, Failure of EGFR TKI
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lazertinib(YH25448)Drug
- lazertinib 240mg(3tablets, 80mg/1tablet), once a day, oral, before disease progression
| Study group | Role | What they receive |
|---|---|---|
| lazertinib(YH25448) | Experimental | lazertinib 240mg, once a day, oral, before disease progression Receives: Drug: lazertinib(YH25448) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial objective response rates (iORR) (RECIST1.1)
iORR will be evaluated according to RECIST v1.1 after IP administration and Response data will be used for the primary endpoint.
Measured: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (8)
intracranial progression free survival, iPFS
the date of onset of objective intracranial disease progression or death of any cause, whichever occurs first.
Measured: Up to 2 years
iORR in T790M negative, isolated CNS progression patient group
iORR will be evaluated according to RECIST v1.1 after IP administration
Measured: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
overall ORR
ORR will be evaluated according to RECIST v1.1 after IP administration.
Measured: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
duration of response, DoR
Duration from the date of the first documented confirmatory response(CR or PR) to the date of documented disease progression or death (equivalent to the date of the PFS event)
Measured: Up to 2 years
disease control rate, DCR
the percentage of subjects whose response is CR, PR, responding, or SD.
Measured: Up to 2 years
overall survival, OS
the period from the first administration of the investigational drug to the date of death from any cause.
Measured: Up to 2 years
treatment failure pattern
intracranial progression or extracranial progression or both
Measured: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
salvage intracranial treatment rate
the percentag of subjects who received salvage treatment(surgery or radiation therapy) due to intracranial disease progression.
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.
- First posted13 Apr 2022
- Study start23 Jun 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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 Lung NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Hyoung Kang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Hyoung Kang, Seoul St. Mary's Hospital
- Investigators
- Jin Hyoung Kang, Study chair, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326425
- Sponsor's protocol ID
- LU20-15
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goss G, Tsai CM, Shepherd FA, Ahn MJ, Bazhenova L, Crino L, de Marinis F, Felip E, Morabito A, Hodge R, Cantarini M, Johnson M, Mitsudomi T, Janne PA, Yang JC. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two phase II trials. Ann Oncol. 2018 Mar 1;29(3):687-693. doi: 10.1093/annonc/mdx820.
PubMed 29293889Yun J, Hong MH, Kim SY, Park CW, Kim S, Yun MR, Kang HN, Pyo KH, Lee SS, Koh JS, Song HJ, Kim DK, Lee YS, Oh SW, Choi S, Kim HR, Cho BC. YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 15;25(8):2575-2587. doi: 10.1158/1078-0432.CCR-18-2906. Epub 2019 Jan 22.
PubMed 30670498Ahn MJ, Han JY, Lee KH, Kim SW, Kim DW, Lee YG, Cho EK, Kim JH, Lee GW, Lee JS, Min YJ, Kim JS, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Kim HT, Lee DH, Kim S, Cho BC. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1-2 study. Lancet Oncol. 2019 Dec;20(12):1681-1690. doi: 10.1016/S1470-2045(19)30504-2. Epub 2019 Oct 3.
PubMed 31587882Hong MH, Choi YJ, Ahn HK, Lim SM, Keam B, Kim DW, Kim TM, Youk J, Kim YJ, Hwang S, Kim S, Kim JW, Kim HR, Kang JH. Lazertinib in EGFR-Variant Non-Small Cell Lung Cancer With CNS Failure to Prior EGFR Tyrosine Kinase Inhibitors: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Oct 1;10(10):1342-1351. doi: 10.1001/jamaoncol.2024.2640.
PubMed 39145962
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lazertinib in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Metastatic Non-Small Cell Lung Cancer With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR Tyrosine Kinase Inhibitor
- ClinicalTrials.gov ID
- NCT05326425
- Acronym / sponsor ID
- LU20-15
- Conditions
- Lung Neoplasms
- Keywords
- NSCLC, Brain Metastases, Failure of EGFR TKI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jin Hyoung KangUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Apr 2022 (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.
This is an open-label, single-intervention, multicenter clinical trial in patients with non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after failure of EGFR TKI treatment. The objective of this study is as follows.
- Primary objective : intracranial objective response rate (iORR) with RECIST 1.1
- Secondary objectives : intracranial progression free survival(iPFS), Intracranial objective response rate in T790M negative, isolated CNS progression patient group, overall Objective Rsponse Rate(ORR), duration of response(DoR), disease control rate(DCR), treatment failure pattern): intracranial progression or extracranial progression or both, salvage intracranial treatment rate, safety and tolerability
Detailed description
Patients who eligible the inclusion/exclusion criteria should take lazertinib 240 mg (80 mg, 3 tablets) once a day at the same time as possible on an empty stomach before meals. One cycle of treatment is defined as 42 days of continuous administration, and the tumor response by RECIST 1.1 will be evaluated every 1 cycle for the 1st, 2nd, 3rd, and 4th evaluation, and every 2 cycles from the 5th evaluation thereafter. .
If the investigator decides to reduce the dose due to an adverse drug reaction during the administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of lazertinib.
Efficacy and safety will be evaluated by administering lazertinib 240 mg to patients with measurable brain metastasis or newly confirmed metastatic non-small cell lung cancer after failure of treatment with gefitinib, erlotinib, or afatinib after EGFR mutation is confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lazertinib(YH25448) | Experimental | Drug: lazertinib(YH25448)lazertinib 240mg, once a day, oral, before disease progression |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who voluntarily provided written informed consent prior to participation in the clinical trial and genetics and/or exploratory studies
- Male or female, 20 years of age or older(Female patients must agree to the use of appropriate contraceptive methods and not be lactating, and for women of childbearing age, there must be evidence that the pregnancy test is negative prior to initiation of dosing)
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer patients. This may occur as systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/C or IV disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, with no deterioration in the last 2 weeks
- Life expectancy judged by the Investigator of at least 3 months
Key exclusion criteria (19 listed)
- Prior treatment with lazertinib
- Prior treatment with investigational drugs in other clinical trials within 30 days prior to the first administration
- Patients who received cytotoxic chemotherapy for the treatment of advanced non-small cell lung cancer or other anticancer drugs other than EGFR TKI within 14 days prior to the first administration of the investigational drug
- Prior local-regional therapy within 4 weeks prior to Day 1 of trial treatment (e.g., major surgery, radiation therapy [with the exception of palliative bone-directed radiotherapy and radiotherapy administered to superficial lesions], hepatic arterial embolization, transcatheter arterial chemoembolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
- Patients currently receiving drugs or herbal supplements known as inhibitors or inducers of CYP3A4 or who cannot discontinue use at least 1 week prior to the first dose of lazertinib.
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 |
|---|---|---|
| lazertinib(YH25448)- lazertinib 240mg(3tablets, 80mg/1tablet), once a day, oral, before disease progression | Drug | lazertinib(YH25448) |
Primary outcome
Intracranial objective response rates (iORR) (RECIST1.1)
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
iORR will be evaluated according to RECIST v1.1 after IP administration and Response data will be used for the primary endpoint.
8 secondary outcomes
intracranial progression free survival, iPFS
Time frame: Up to 2 years
iORR in T790M negative, isolated CNS progression patient group
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
overall ORR
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
duration of response, DoR
Time frame: Up to 2 years
disease control rate, DCR
Time frame: Up to 2 years
overall survival, OS
Time frame: Up to 2 years
treatment failure pattern
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
salvage intracranial treatment rate
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Results publication: PubMed 29293889Goss G, Tsai CM, Shepherd FA, Ahn MJ, Bazhenova L, Crino L, de Marinis F, Felip E, Morabito A, Hodge R, Cantarini M, Johnson M, Mitsudomi T, Janne PA, Yang JC. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two phase II trials. Ann Oncol. 2018 Mar 1;29(3):687-693. doi: 10.1093/annonc/mdx820.
- Results publication: PubMed 30670498Yun J, Hong MH, Kim SY, Park CW, Kim S, Yun MR, Kang HN, Pyo KH, Lee SS, Koh JS, Song HJ, Kim DK, Lee YS, Oh SW, Choi S, Kim HR, Cho BC. YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 15;25(8):2575-2587. doi: 10.1158/1078-0432.CCR-18-2906. Epub 2019 Jan 22.
- Results publication: PubMed 31587882Ahn MJ, Han JY, Lee KH, Kim SW, Kim DW, Lee YG, Cho EK, Kim JH, Lee GW, Lee JS, Min YJ, Kim JS, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Kim HT, Lee DH, Kim S, Cho BC. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1-2 study. Lancet Oncol. 2019 Dec;20(12):1681-1690. doi: 10.1016/S1470-2045(19)30504-2. Epub 2019 Oct 3.
- Derived from this study: PubMed 39145962Hong MH, Choi YJ, Ahn HK, Lim SM, Keam B, Kim DW, Kim TM, Youk J, Kim YJ, Hwang S, Kim S, Kim JW, Kim HR, Kang JH. Lazertinib in EGFR-Variant Non-Small Cell Lung Cancer With CNS Failure to Prior EGFR Tyrosine Kinase Inhibitors: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Oct 1;10(10):1342-1351. doi: 10.1001/jamaoncol.2024.2640.
- 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.
Jin Hyoung Kang study chair
Seoul St. Mary's Hospital, The Catholic University of Korea
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lazertinib(YH25448) in people with Lung Neoplasms, run by Jin Hyoung Kang at 6 sites 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 10 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Hyoung Kang (82-2-2258-6043, oncologykang@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial objective response rates (iORR) (RECIST1.1) (time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 NCT05326425, 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 20 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.