Metastatic Lung Non-Small Cell CarcinomaNCT05377788
Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
An observational study of Metastatic Lung Non-Small Cell Carcinoma and EGFR T790M, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients 1. Primary Purpose: Progression-free survival (PFS) 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Lung Non-Small Cell Carcinoma, EGFR T790M
- What is being tested?
- Lazertinib
- How many people
- 900 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2022to 30 Jun 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Retrospective cohort: 300 people Prospective cohort: 600 people
Who may be able to join
- Prospective cohort
- adults over the age of 19
- Easter Cooperative Oncology Group performance 0-4
- Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI
- EGFR T790M mutation allows for all results identified in tumor tissue or plasma
- Patients with brain MR within 3 months of study participation
Show all 9Show fewer
- Rectrospective cohort
- adults over the age of 19
- Patients who are already using the test drug according to the domestic authorization of the test drug
Who cannot join
- Patients who have a history of hypersensitivity to test drugs or drugs of similar chemical structure or similar family to those of test drugs
- Pregnant women or lactating women
- Patients participating in other interventional clinical studies
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, 06351
Jin Seok Ahn, MD, PhD
About this study
- It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients
- Primary Purpose: Progression-free survival (PFS)
- Secondary Purpose:
- Objective response rate
- Time to treatment failure
- Adverse event (AE), serious adverse event (SAE), and adverse event of special interest (AESI)
- Severity of (S)AE
- duration of response (DoR)
- Overall survival (OS)
- Intravenous Progressive Survival Period (Intracranial PFS)
- Relative dose intensity
- Research Design : a Multi-Center Prospective and Restrospective Cohort Study
Read the detailed description
□ the purpose of the study The study aims to explore the safety, efficacy and resistance of test drugs in patients with local progressive or metastatic epithelial growth factor T790M mutant non-small cell lung cancer who have been treated with epithelial growth factor receptor tyrosine kinase inhibitors.
This study is conducted in Korea. About 600 patients will be monitored until the first occurrence of disease progression, withdrawal of consent, failure of follow-up investigation, and death.
□ Research Procedures and Information Gathering Items There are no additional procedures performed by participating in this study and information on safety and effectiveness during the administration of Rexhraza will be followed up in routine care situations.
The information you will receive when you participate in this study is as follows.
- Subject characteristics, including age, gender, and race
- T790M Positive Mutation Status Results and Types of Tests Performed and Receptors
- a related medical history
- a physical examination
- disease characteristics
- history of chemotherapy
- associated concomitant medications
- administration of a test drug
- Safety and effectiveness
- Resistance mechanism in plasma circulation tumor DNA
- Being tested
- Lazertinib
- 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.
LazertinibDrug
Also called LECLAZA
Treatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | * Inclusion criteria
* adults over the age of 19
* Easter Cooperative Oncology Group performance 0-4
* Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI
* EGFR T790M mutation allows for all results identified in tumor tissue or plasma
* Patients with brain MR within 3 months of study participation
* After obtaining a consent form for research participation, follow-up and monitoring survival information and safety information. Survival follow-up of prospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death. Receives: Drug: Lazertinib | |
| Restrospective cohort | * Inclusion criteria
* adults over the age of 19
* Patients who are already using the lazertinib according to the domestic authorization of lazertinib(This includes when participants receive interventions as part of routine medical care)
* Survival information is monitored after the time when the consent form for participation in the study is obtained. Survival follow-up of retrospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death Receives: Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from study enrollment until objective disease progression or death.
Measured: Through study completion, an average of 3 years
Secondary outcomes (6)
Objective response rate (ORR)
Objective response rate is defined as the proportion of patients who have a partial or complete response to therapy.
Measured: Through study completion, an average of 3 years
Time to treatment failure (TTF)
Time to treatment failure (TTF) is defined as the interval between initiating therapy and the earliest of clinical progression, new locally directed or systemic treatment other than lazertinib.
Measured: Through study completion, an average of 3 years
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment to death.
Measured: Through study completion, an average of 3 years
Duration of response (DoR)
Duration of response (DoR) is the length of time that a tumor continues to respond to treatment without cancer growing or spreading.
Measured: Through study completion, an average of 3 years
Intracranial Progression-free survival (Intracranial PFS)
Intracranial PFS is defined as the time from study enrollment until objective intracranial progression.
Measured: Through study completion, an average of 3 years
Relative dose intensity
Relative dose intensity is defined as the actual dose received divided by the standard calculated dose during a predefined period.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start31 Jul 2022 (estimated)
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Lung Non-Small Cell CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 900 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Seok Ahn, MD, Samsung Medical Center
- Investigators
- Jin Seok Ahn, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377788
- Sponsor's protocol ID
- KCSG LU22-01
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Nguyen KS, Kobayashi S, Costa DB. Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancers dependent on the epidermal growth factor receptor pathway. Clin Lung Cancer. 2009;10:281-9. 2. Dhillon S. Lazertinib: First Approval. Drugs. 2021;81:1107-13. 3. Ahn M-J, Han J-Y, Lee KH, Kim S-W, Kim D-W, Lee Y-G, et al. 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. The Lancet Oncology. 2019;20:1681-90. 4. Yun J, Hong MH, Kim SY, Park CW, Kim S, Yun MR, et al. YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2019;25:2575-87
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05377788
- Acronym / sponsor ID
- KCSG LU22-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 31 Jul 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 May 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.
- It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients
- Primary Purpose: Progression-free survival (PFS)
- Secondary Purpose:
- Objective response rate
- Time to treatment failure
- Adverse event (AE), serious adverse event (SAE), and adverse event of special interest (AESI)
- Severity of (S)AE
- duration of response (DoR)
- Overall survival (OS)
- Intravenous Progressive Survival Period (Intracranial PFS)
- Relative dose intensity
- Research Design : a Multi-Center Prospective and Restrospective Cohort Study
Detailed description
□ the purpose of the study The study aims to explore the safety, efficacy and resistance of test drugs in patients with local progressive or metastatic epithelial growth factor T790M mutant non-small cell lung cancer who have been treated with epithelial growth factor receptor tyrosine kinase inhibitors.
This study is conducted in Korea. About 600 patients will be monitored until the first occurrence of disease progression, withdrawal of consent, failure of follow-up investigation, and death.
□ Research Procedures and Information Gathering Items There are no additional procedures performed by participating in this study and information on safety and effectiveness during the administration of Rexhraza will be followed up in routine care situations.
The information you will receive when you participate in this study is as follows.
- Subject characteristics, including age, gender, and race
- T790M Positive Mutation Status Results and Types of Tests Performed and Receptors
- a related medical history
- a physical examination
- disease characteristics
- history of chemotherapy
- associated concomitant medications
- administration of a test drug
- Safety and effectiveness
- Resistance mechanism in plasma circulation tumor DNA
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Drug: Lazertinib* Inclusion criteria * adults over the age of 19 * Easter Cooperative Oncology Group performance 0-4 * Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI * EGFR T790M mutation allows for all results identified in tumor tissue or plasma * Patients with brain MR within 3 months of study participation * After obtaining a consent form for research participation, follow-up and monitoring survival information and safety information. Survival follow-up of prospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death. |
| Restrospective cohort | – | Drug: Lazertinib* Inclusion criteria * adults over the age of 19 * Patients who are already using the lazertinib according to the domestic authorization of lazertinib(This includes when participants receive interventions as part of routine medical care) * Survival information is monitored after the time when the consent form for participation in the study is obtained. Survival follow-up of retrospective cohorts will be followed up to the point of first occurrence during disease progression, withdrawal of consent, failure of follow-up investigation, and death |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort: 300 people Prospective cohort: 600 people
Key inclusion criteria (9 listed)
- Prospective cohort
- Rectrospective cohort
Key exclusion criteria (3 listed)
- Patients who have a history of hypersensitivity to test drugs or drugs of similar chemical structure or similar family to those of test drugs
- Pregnant women or lactating women
- Patients participating in other interventional clinical studies
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 |
|---|---|---|
| LazertinibAlso: LECLAZATreatment of EGFR T790M mutant-positive local progressive or metastatic non-small cell lung cancer patients who have previously been treated with EGFR | Drug | Prospective cohort, Restrospective cohort |
Primary outcome
Progression-free survival (PFS)
Time frame: Through study completion, an average of 3 years
Progression-free survival (PFS) is defined as the time from study enrollment until objective disease progression or death.
6 secondary outcomes
Objective response rate (ORR)
Time frame: Through study completion, an average of 3 years
Time to treatment failure (TTF)
Time frame: Through study completion, an average of 3 years
Overall survival (OS)
Time frame: Through study completion, an average of 3 years
Duration of response (DoR)
Time frame: Through study completion, an average of 3 years
Intracranial Progression-free survival (Intracranial PFS)
Time frame: Through study completion, an average of 3 years
Relative dose intensity
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background1. Nguyen KS, Kobayashi S, Costa DB. Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancers dependent on the epidermal growth factor receptor pathway. Clin Lung Cancer. 2009;10:281-9. 2. Dhillon S. Lazertinib: First Approval. Drugs. 2021;81:1107-13. 3. Ahn M-J, Han J-Y, Lee KH, Kim S-W, Kim D-W, Lee Y-G, et al. 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. The Lancet Oncology. 2019;20:1681-90. 4. Yun J, Hong MH, Kim SY, Park CW, Kim S, Yun MR, et al. YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2019;25:2575-87
- 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 Seok 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?
An observational study of Metastatic Lung Non-Small Cell Carcinoma and EGFR T790M, 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 9 inclusion and 3 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 19 May 2022. 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.
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 Shinkyo Yoon, MD (+82-10-7232-2502, shinkyoyoon@amc.seoul.kr), 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: Through study completion, an average of 3 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 NCT05377788, which also lists 1 linked publication.
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 19 May 2022.