NSCLCPhase 2NCT05463224
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
A Phase 2 study testing Lazertinib group in people with NSCLC, run by Sehhoon Park at 1 site in South Korea.
Trial summary
The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Lazertinib group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2023to 31 Dec 2027
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible.
- Stage IIIC or IV by AJCC 8th edition
- Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)
- Age of 19 or more.
- Performance status of Eastern Cooperative Oncology Group 0 to 2.
- Expected minimum life expectancy of 12 weeks
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- Adequate organ function.
- Available to provide the adequate tissue and blood for the genomic tests- At least 15 unstained slide and 20 cc of blood at baseline (mandatory) and disease progression.
- Agreed to perform re-biopsy at the timepoint of disease progression.
- At least two weeks after the chemotherapy
- Female subjects must either be of non-reproductive potential
- Subject willing and able to comply with the protocol
- Signed written informed consent
Who cannot join
- Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)
- Uncontrolled central nervous system metastases- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled.
- Spinal cord compression, leptomeningeal carcinomatosis
- Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
- Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week
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- Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
- Mean QT interval corrected for heart rate (QTc) ≥ 470 ms
- No measurable lesion
- Unable to swallow the product due to refractory nausea, vomiting or chornic gastrointestinal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients: A Single-arm, Phase II Single-center Trial
The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.
Read the detailed description
As the 3rd generation EGFR TKI become a standard treatment option for the 1st line therapy in EGFR mutated patients, necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. The idea of understanding the exact resistance mechanism to 1st line 3rd generation EGFR TKI treatment is emphasized based on the observation that resistance mechanism is different based on osimertinib used as 1st line or 2nd line treatment.6,7 Although resistance mechanisms to lazertinib in patients with prior EGFR TKI treatment have been studied, there are no current data available regarding the resistance mechanism after first-line lazertinib treatment.
Based on this observation, PI designed this study to elucidate the efficacy/safety of Lazertinib and to explore resistance mechanisms of 1st line lazertinib treatment in NSCLC patients with activating EGFR mutation.
- Conditions
- NSCLC
- Being tested
- Lazertinib group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lazertinib groupDrug
Also called Leclaza
Lazertinib 240mg, Once, po, daily (1 cycle of 21 days)
| Study group | Role | What they receive |
|---|---|---|
| Lazertinib group | Experimental | Lazertinib 240mg daily (1 cycle of 21 days) Receives: Drug: Lazertinib group |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
C1D1 until the date of objective disease progression or death
Measured: through study completion, an average of 18.0 month
Resistance mechanism analysis
The mutation profile of baseline and at the timepoint of resistance will be evaluated using tissue and cfDNA
Measured: Screening, Discontiunuation Visit
Secondary outcomes (7)
Objective response rate (ORR)
as the percentage of patients with measurable disease with at least one visit response of complete response (CR) or partial response (PR)
Measured: through study completion, an average of 18.0 month
Duration of Response (DoR)
as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first
Measured: through study completion, an average of 18.0 month
Disease control rate (DCR)
as the percentage of patients who have a best overall response of CR or PR or stable disease (SD at ≥ 6 weeks, prior to any PD event)
Measured: through study completion, an average of 18.0 month
Overall survival (OS)
s the time from the date of C1D1 until the date of death due to any cause
Measured: through study completion, an average of 18.0 month
intracranial PFS (iPFS)
as the time from C1D1 until the date of objective intracranial disease progression or death whichever comes first in patients for the iFAS
Measured: through study completion, an average of 18.0 month
intracranial ORR (iORR)
as the percentage of patients who have at least 1 CR or PR in intracranial lesion, according to RECIST v1.1 prior to disease progression in patients who have at least one measurable intracranial lesion at baseline
Measured: through study completion, an average of 18.0 month
intracranial DCR (iDCR)
as the percentage of patients who have a best intracranial overall response of CR or PR or SD in patients who have at least one measurable intracranial lesion at baseline
Measured: through study completion, an average of 18.0 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start4 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Model description
- A single-arm, phase II single-center trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehhoon Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sehhoon Park, Samsung Medical Center
- Investigators
- Sehhoon Park, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463224
- Sponsor's protocol ID
- 2022-09-029
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients: A Single-arm, Phase II Single-center Trial
- ClinicalTrials.gov ID
- NCT05463224
- Acronym / sponsor ID
- 2022-09-029
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sehhoon ParkUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jul 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.
The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.
Detailed description
As the 3rd generation EGFR TKI become a standard treatment option for the 1st line therapy in EGFR mutated patients, necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. The idea of understanding the exact resistance mechanism to 1st line 3rd generation EGFR TKI treatment is emphasized based on the observation that resistance mechanism is different based on osimertinib used as 1st line or 2nd line treatment.6,7 Although resistance mechanisms to lazertinib in patients with prior EGFR TKI treatment have been studied, there are no current data available regarding the resistance mechanism after first-line lazertinib treatment.
Based on this observation, PI designed this study to elucidate the efficacy/safety of Lazertinib and to explore resistance mechanisms of 1st line lazertinib treatment in NSCLC patients with activating EGFR mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, phase II single-center trial
| Arm | Type | Receives |
|---|---|---|
| Lazertinib group | Experimental | Drug: Lazertinib groupLazertinib 240mg daily (1 cycle of 21 days) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible.
- Stage IIIC or IV by AJCC 8th edition
- Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)
- Age of 19 or more.
- Performance status of Eastern Cooperative Oncology Group 0 to 2.
Key exclusion criteria (10 listed)
- Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)
- Uncontrolled central nervous system metastases- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled.
- Spinal cord compression, leptomeningeal carcinomatosis
- Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
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 groupAlso: LeclazaLazertinib 240mg, Once, po, daily (1 cycle of 21 days) | Drug | Lazertinib group |
Primary outcome
progression-free survival
Time frame: through study completion, an average of 18.0 month
C1D1 until the date of objective disease progression or death
Resistance mechanism analysis
Time frame: Screening, Discontiunuation Visit
The mutation profile of baseline and at the timepoint of resistance will be evaluated using tissue and cfDNA
7 secondary outcomes
Objective response rate (ORR)
Time frame: through study completion, an average of 18.0 month
Duration of Response (DoR)
Time frame: through study completion, an average of 18.0 month
Disease control rate (DCR)
Time frame: through study completion, an average of 18.0 month
Overall survival (OS)
Time frame: through study completion, an average of 18.0 month
intracranial PFS (iPFS)
Time frame: through study completion, an average of 18.0 month
intracranial ORR (iORR)
Time frame: through study completion, an average of 18.0 month
intracranial DCR (iDCR)
Time frame: through study completion, an average of 18.0 month
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 28 Jul 2026.
- 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.
Sehhoon Park, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lazertinib group in people with NSCLC, run by Sehhoon Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: through study completion, an average of 18.0 month). 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?
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 28 Jul 2026.