Non Small Cell Lung CancerPhase 2NCT05167851
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
A Phase 2 study testing Lazertinib , a combination group of SBRT and Lazertinib single administration group in people with Non Small Cell Lung Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
This is based on the observations that disease progression under EGFR(Epidermal Growth Factor Receptor) targeting TKI(Tyrosine Kinase Inhibitor) most frequently occurs at the original sites of metastatic disease and that the majority of patients shows disease progression in a limited number of metastatic lesions, a… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Lazertinib , a combination group of SBRT and Lazertinib single administration group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2021to Dec 2025
- 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
- Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation.
- Presence of the sensitising EGFR-mutation (exon 19 deletion and/or L858R) detected by an accredited laboratory.
- Synchronous oligometastatic stage IV disease (max 5 lesions)
- Measurable disease as defined according to RECIST v1.1
- All lesions amenable for radical radiotherapy according to local judgment
- Age ≥18 years
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- ECOG performance status 0-2
- Life expectancy ≥12 months
- Adequate haematological function:
- Hemoglobin 90 g/L
- Absolute neutrophil count (ANC) 1.5× 109/L
- Platelet count 100× 109/L
- Adequate renal function:
- Serum creatinine 1.5x ULN or creatinine clearance ≥50 mL/min (calculated according to Cockcroft-Gault, see below). Confirmation of creating clearance is only required when serum creatinine is >1.5x ULN.
- Adequate liver function:
- ALT and AST 2.5× ULN. If the patient has liver metastases, ALT and AST must be ≤5× ULN
- Total serum bilirubin 1.5× ULN. If the patient has documented Gilbert's syndrome (unconjugated hyperbilirubinaemia) 3× ULN.
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 7 days before enrolment.
- Written IC for protocol treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention.
Who cannot join
- Prior chemotherapy, immunotherapy, radiotherapy or therapeutical surgery for NSCLC (an exception is the resection of CNS or adrenal metastases)
- More than 5 distant oligometastases (any second intra-thoracic lesion will count as a distant metastasis; regional nodal metastases will not count to the 5 oligometastases) and more than 2 intra-thoracic lesions.
- Brain metastases not amenable for radiosurgery or neurosurgery
- Presence of leptomeningeal metastases
- Symptomatic spinal cord compression
- Extracranial metastatic locations such as malignant ascites, pleural or pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques.
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- Currently receiving (or unable to stop use prior to receiving the first dose of lazertinib treatment) medications or herbal supplements known to be potent CYP3A4 inducers that cannot be stopped before enrolment and for the duration of the trial.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol.
- Patients with a resolved or chronic HBV infection are eligible if they are:
- Negative for HBsAg and positive for hepatitis B core antibody [anti-HBc IgG] or
- Positive for HBsAg, negative for HBeAg but for >6 months have had transaminases levels below ULN and HBV DNA levels below 2000 IU/mL (i.e., are in an inactive carrier state).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of lazertinib
- Any of the following cardiac criteria:
- QTcF >470 msec obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value (QTcF: corrected QT interval using Fredericia's formula).
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block or second degree heart block).
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP).
- Past medical history of ILD, drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Idiopathic pulmonary fibrosis which is a contraindication to lung radiation.
- History of hypersensitivity to active or inactive excipients of lazertinib or drugs with a similar chemical structure or class to lazertinib.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements Women who are pregnant or in the period of lactation.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method (Please refer to 8.4 for highly effective contraceptive methods) during the trial and up to 6 weeks for women and up to 4 months for men, after discontinuing lazertinib treatment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
Sun min Lim, +82-2227-8296, limlove2008@yuhs.ac
About this study
Official title: A Multicentre Two-arm, Phase II Trial Assessing the Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
This is based on the observations that disease progression under EGFR(Epidermal Growth Factor Receptor) targeting TKI(Tyrosine Kinase Inhibitor) most frequently occurs at the original sites of metastatic disease and that the majority of patients shows disease progression in a limited number of metastatic lesions, a situation defined as oligoprogression.
All studies reported a significantly and clinically relevant improved OS(Overall Survival) or PFS(Period Free Survival) for adding locally ablative therapy to standard of care systemic therapy. However, these studies included only very few NSCLC(non small cell lunc cancer) patients with activating driver mutations and the benefit of adding upfront local radiotherapy might be smaller or larger in this NSCLC(non small cell lunc cancer) patient population with activating driver mutations and treatment with TKIs(Tyrosine Kinase Inhibitor) smaller because of the higher systemic efficacy of TKIs(Tyrosine Kinase Inhibitor) compared to chemotherapy or larger because the benefit of local treatment might become most obvious if potential microscopic disease is successfully controlled by TKI(Tyrosine Kinase Inhibitor)s .Consequently, there is a clinical need to evaluate locally ablative therapy in oligometastatic EGFR (Epidermal Growth Factor Receptor) -mutant NSCLC(non small cell lunc cancer) patients and simultaneously a strong rational that this population might benefit in particular from a combined modality treatment: the benefit of locally ablative therapy is expected to be largest in situations of effective systemic therapies to control locally untreated microscopic disease which is true for EGFR (Epidermal Growth Factor Receptor) targeting.
The investigator therefore propose a prospective two-arm phase II study, which aims to evaluate safety and efficacy of lazertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligometastatic (primary tumour and maximum 5 metastases) EGFR (Epidermal Growth Factor Receptor) -mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS(Period Free Survival) and OS(Overall Survival) without added high-grade toxicity.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Lazertinib , a combination group of SBRT, Lazertinib single administration group
- 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.
Lazertinib , a combination group of SBRTDrug
- Lazertinib 240mg once a day(QD) oral(PO)
-If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year.
Lazertinib single administration groupDrug
- Lazertinib 240mg once a day(QD) oral(PO)
-If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year.
| Study group | Role | What they receive |
|---|---|---|
| Lazertinib, a combination group of SBRT | Experimental | * Lazertinib 240mg once a day(QD) oral(PO)
-If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year.
* Stereotactic Body Radiation Therapy (SBRT) to oligometastatic sites SBRT(Stereotactic Body Radiation Therapy) will be delivered to the primary tumour and to all metastatic sites. SBRT(Stereotactic Body Radiation Therapy) will be delivered using risk-adapted SBRT with a maximum of 5 SBRT(Stereotactic Body Radiation Therapy) fractions. Receives: Drug: Lazertinib , a combination group of SBRT |
| Lazertinib single administration group | Active comparator | * Lazertinib 240mg once a day(QD) oral(PO)
-If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year. Receives: Drug: Lazertinib single administration group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The time to recurrence/progression/death and From start of Lazertinib to documented radiographic relapse/progression by RECIST 1.1 criteria
Measured: every 8 weeks after enrollment, an average of one year
Progression free survival (PFS)
The time to recurrence/progression/death and From start of Lazertinib to documented radiographic relapse/progression by RECIST 1.1 criteria
Measured: disease progression, an average of one year
Secondary outcomes (7)
Overall Survival (OS)
Overall survival (OS) is defined as the time from the date of enrolment until death from any cause. Censoring will occur at the last follow-up date.
Measured: Every 12 weeks after the end of the study , which will be conducted in about 3 years.
Distant Progression free survival (Distant PFS)
Distant PFS is defined as the time from date of enrollment until development of new metastases, excluding oligometastases diagnosed at enrolment.
Measured: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Objective response rate (ORR)
Objective response rate (ORR) is defined as the percentage of patients that achieve a best overall response [complete response (CR) or partial response (PR)] according to RECIST v1.1 from enrolment across all trial assessment time-points.
Measured: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Duration of Response (DoR)
Duration of Response (DoR) is defined as the interval from the date of first documentation of objective response (CR or PR, according to RECIST v1.1) to the date of first documented progression, relapse or death.
Measured: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Adverse event according to CTCAE(Common Terminology Criteria for Adverse Event) v5.0
AE captured by CYCAE 5.0 until after 30days of last administration.
Measured: Screening, every cycle visit and End of study, and evaluation up to 6 weeks after End of the study. This is is expected to be an average of one year.
Pattern of disease progression
The pattern of disease progression is defined as the site of first progression: None, locoregional, distant (bone, brain, liver, etc) or both locoregional and distant, evaluated up to 18-months post enrollment.
Measured: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Exploratory analysis (Analysis of acquired resistance mechanism through cfDNA)
- Analysis of acquired resistance mechanisms to lazertinib plus radiotherapy at the time of progression using tumor/liquid cfDNA biopsy
Measured: At Screening and disease progression. This is expected to be an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun min Lim, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167851
- Sponsor's protocol ID
- 4-2021-1227
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tu CY, Hsia TC, Lin YC, Liang JA, Li CC, Chien CR. Efficacy of Definitive Radiotherapy for Patients with Clinical Stage IIIB or IIIC Lung Adenocarcinoma and Epidermal Growth Factor Receptor (EGFR) Mutations Treated Using First- or Second-Generation EGFR Tyrosine Kinase Inhibitors. Can Respir J. 2024 Mar 5;2024:8889536. doi: 10.1155/2024/8889536. eCollection 2024.
PubMed 38476120Kim KH, Yoon S, Ahn HK, Lee SY, Lee GW, Lee SS, Cho JH, Cho BC, Yoon HI, Lim SM. A Multicenter Two-arm, Phase II Trial Assessing the Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer (ABLATE, KCSG-LU21-11). Clin Lung Cancer. 2022 Dec;23(8):e536-e539. doi: 10.1016/j.cllc.2022.07.014. Epub 2022 Aug 7.
PubMed 36002368
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Two-arm, Phase II Trial Assessing the Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05167851
- Acronym / sponsor ID
- 4-2021-1227
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Dec 2021 (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 based on the observations that disease progression under EGFR(Epidermal Growth Factor Receptor) targeting TKI(Tyrosine Kinase Inhibitor) most frequently occurs at the original sites of metastatic disease and that the majority of patients shows disease progression in a limited number of metastatic lesions, a situation defined as oligoprogression.
All studies reported a significantly and clinically relevant improved OS(Overall Survival) or PFS(Period Free Survival) for adding locally ablative therapy to standard of care systemic therapy. However, these studies included only very few NSCLC(non small cell lunc cancer) patients with activating driver mutations and the benefit of adding upfront local radiotherapy might be smaller or larger in this NSCLC(non small cell lunc cancer) patient population with activating driver mutations and treatment with TKIs(Tyrosine Kinase Inhibitor) smaller because of the higher systemic efficacy of TKIs(Tyrosine Kinase Inhibitor) compared to chemotherapy or larger because the benefit of local treatment might become most obvious if potential microscopic disease is successfully controlled by TKI(Tyrosine Kinase Inhibitor)s .Consequently, there is a clinical need to evaluate locally ablative therapy in oligometastatic EGFR (Epidermal Growth Factor Receptor) -mutant NSCLC(non small cell lunc cancer) patients and simultaneously a strong rational that this population might benefit in particular from a combined modality treatment: the benefit of locally ablative therapy is expected to be largest in situations of effective systemic therapies to control locally untreated microscopic disease which is true for EGFR (Epidermal Growth Factor Receptor) targeting.
The investigator therefore propose a prospective two-arm phase II study, which aims to evaluate safety and efficacy of lazertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligometastatic (primary tumour and maximum 5 metastases) EGFR (Epidermal Growth Factor Receptor) -mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS(Period Free Survival) and OS(Overall Survival) without added high-grade toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lazertinib, a combination group of SBRT | Experimental | Drug: Lazertinib , a combination group of SBRT* Lazertinib 240mg once a day(QD) oral(PO) -If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year. * Stereotactic Body Radiation Therapy (SBRT) to oligometastatic sites SBRT(Stereotactic Body Radiation Therapy) will be delivered to the primary tumour and to all metastatic sites. SBRT(Stereotactic Body Radiation Therapy) will be delivered using risk-adapted SBRT with a maximum of 5 SBRT(Stereotactic Body Radiation Therapy) fractions. |
| Lazertinib single administration group | Active comparator | Drug: Lazertinib single administration group* Lazertinib 240mg once a day(QD) oral(PO) -If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation.
- Presence of the sensitising EGFR-mutation (exon 19 deletion and/or L858R) detected by an accredited laboratory.
- Synchronous oligometastatic stage IV disease (max 5 lesions)
- Measurable disease as defined according to RECIST v1.1
- All lesions amenable for radical radiotherapy according to local judgment
Key exclusion criteria (21 listed)
- Prior chemotherapy, immunotherapy, radiotherapy or therapeutical surgery for NSCLC (an exception is the resection of CNS or adrenal metastases)
- More than 5 distant oligometastases (any second intra-thoracic lesion will count as a distant metastasis; regional nodal metastases will not count to the 5 oligometastases) and more than 2 intra-thoracic lesions.
- Brain metastases not amenable for radiosurgery or neurosurgery
- Presence of leptomeningeal metastases
- Symptomatic spinal cord compression
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 , a combination group of SBRT* Lazertinib 240mg once a day(QD) oral(PO) -If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year. | Drug | Lazertinib, a combination group of SBRT |
| Lazertinib single administration group* Lazertinib 240mg once a day(QD) oral(PO) -If there is no disease progression or unacceptable toxicity, treatment is performed at 1 cycle (28 days) interval . This is expected to be an average of one year. | Drug | Lazertinib single administration group |
Primary outcome
Progression free survival (PFS)
Time frame: every 8 weeks after enrollment, an average of one year
The time to recurrence/progression/death and From start of Lazertinib to documented radiographic relapse/progression by RECIST 1.1 criteria
Progression free survival (PFS)
Time frame: disease progression, an average of one year
The time to recurrence/progression/death and From start of Lazertinib to documented radiographic relapse/progression by RECIST 1.1 criteria
7 secondary outcomes
Overall Survival (OS)
Time frame: Every 12 weeks after the end of the study , which will be conducted in about 3 years.
Distant Progression free survival (Distant PFS)
Time frame: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Objective response rate (ORR)
Time frame: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Duration of Response (DoR)
Time frame: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Adverse event according to CTCAE(Common Terminology Criteria for Adverse Event) v5.0
Time frame: Screening, every cycle visit and End of study, and evaluation up to 6 weeks after End of the study. This is is expected to be an average of one year.
Pattern of disease progression
Time frame: At screening, every 8 weeks after enrollment, and when the disease progresses. This is expected to be an average of one year.
Exploratory analysis (Analysis of acquired resistance mechanism through cfDNA)
Time frame: At Screening and disease progression. This is expected to be an average of one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 38476120Tu CY, Hsia TC, Lin YC, Liang JA, Li CC, Chien CR. Efficacy of Definitive Radiotherapy for Patients with Clinical Stage IIIB or IIIC Lung Adenocarcinoma and Epidermal Growth Factor Receptor (EGFR) Mutations Treated Using First- or Second-Generation EGFR Tyrosine Kinase Inhibitors. Can Respir J. 2024 Mar 5;2024:8889536. doi: 10.1155/2024/8889536. eCollection 2024.
- Derived from this study: PubMed 36002368Kim KH, Yoon S, Ahn HK, Lee SY, Lee GW, Lee SS, Cho JH, Cho BC, Yoon HI, Lim SM. A Multicenter Two-arm, Phase II Trial Assessing the Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer (ABLATE, KCSG-LU21-11). Clin Lung Cancer. 2022 Dec;23(8):e536-e539. doi: 10.1016/j.cllc.2022.07.014. Epub 2022 Aug 7.
- 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.
Sun min Lim principal investigator
Yonsei University Health System, Severance Hospital
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 Lazertinib , a combination group of SBRT and Lazertinib single administration group in people with Non Small Cell Lung Cancer, run by Yonsei University 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 19 inclusion and 21 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 22 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun min Lim (+82-2227-8296, limlove2008@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: every 8 weeks after enrollment, an average of one year). 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?
On the ClinicalTrials.gov record for NCT05167851, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.