NSCLCPhase 2LU21-16NCT05277701
Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations
A Phase 2 study testing Lazertinib in people with NSCLC, run by Yonsei University at 1 site in South Korea.
Trial summary
The primary objective is to evaluate the antitumor efficacy of lazertinib in patients with NSCLC harboring uncommon EGFR mutations. The primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a complete response or partial response per RECIST v1.1 by investigator's… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Lazertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2022to Dec 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
- 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).
- Confirmed uncommon EGFR mutations (e.g. G719X, S768I, L861Q, G719X + S768I, G719X + L861Q, L861Q + S768I, L747S, S720A, E709A, exon 18 deletion) without common EGFR mutations including exon 19 deletion, L858R, exon 20 insertion, or T790M. (The result from both cell-free DNA or tissue-based DNA is allowed.)
- Age of 20 or more.
- Performance status of Eastern Cooperative Oncology Group 0 to 2.
- At least one measurable lesion by RECIST 1.1(The part of radiation treatment in the palliative setting is excluded.)
- Untreated asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery, and stable and not requiring steroids for at least 2 weeks prior to start of study treatment.
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- At least 2 weeks later after whole brain radiotherapy or palliative thoracic radiotherapy
- Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; hemoglobin > 9.0g/dL; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 2.5 ULN if no demonstrable liver metastases or < 5 UNL in the presence of liver metastases; CCr ≥ 50mL/min
- Written informed consent form
Who cannot join
- Previously treatment with any kind of EGFR TKI
- Uncontrolled central nervous system metastases
- Leptomeningeal carcinomatosis
- Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
- Cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14days of first dose of study treatment, or any investigational drugs within 5 x half-lives of the compound
- Major surgery undertaken less than 4 weeks before the study
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- Localized palliative radiotherapy unless completed more than 2 weeks before the study
- Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method, contraception until 3 months after discontinuation of drug for female, hormonal methods should be used in combination with barrier methods)
- Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer, early gastric cancer or otherwise confirmed as curative malignancy disease by principal investigator
- Any of the following cardiac criteria:
- Prolonged QT interval in ECG (QTc > 450 msec)
- Any clinically important abnormalities in rhythm, conduction conduction or morphology of resting ECG eg complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec
- Any other factors that increase risk of QT 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 yers og age in first degree relatives or concomitant medications known to prolong QT interval
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
MinHee Hong, 82-2-2228-8129, MINHEE_HONG@yuhs.ac
About this study
Official title: Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations: A Single-arm, Phase II Multi-center Trial
The primary objective is to evaluate the antitumor efficacy of lazertinib in patients with NSCLC harboring uncommon EGFR mutations. The primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a complete response or partial response per RECIST v1.1 by investigator's assessments.Secondary endpoints are disease control rate, progression-free survival, overall survival, and duration of response. Secondary objectives are progression-free survival, overall survival, and safety profile according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- Progression-free survival :From C1D1 to the date of either disease progression or death
- Overall survival: From C1D1 to the date of all-cause mortality
- Safety: Evaluated by NCI-CTCAE v5.0
- The exploratory objective is to identify the acquired resistance mechanism to lazertinib in NSCLC with uncommon EGFR mutation.
Lazertinib 240mg daily (1 cycle of 21 days) will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. However, beyond disease progression is allowed based on the investigator's decision. Doses should be taken approximately 24 hours apart at the same time point each day before eating meal under fasting. If it is more than 12 hours after the dose time, the missed dose should not be taken, and patients should be instructed to take the next dose at the next scheduled time.
- Conditions
- NSCLC
- Being tested
- Lazertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LazertinibDrug
Lazertinib 240mg daily (1 cycle of 21 days) will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. However, beyond disease progression is allowed based on the investigator's decision. Doses should be taken approximately 24 hours apart at the same time point each day before eating meal under fasting. If it is more than 12 hours after the dose time, the missed dose should not be taken, and patients should be instructed to take the next dose at the next scheduled time.
| Study group | Role | What they receive |
|---|---|---|
| Lazertinib | Experimental | Not described Receives: Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
It is evaluated by taking CT of the chest and abdomen (including liver and adrenal glands) or MRI .
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
Progression-free survival(PFS)
PFS is measured from the date of start of study to the date of disease progression or death from any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
OS is measured from the date of start of study to the date of death from any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and toxicity profile evaluated throughout the study participation period.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 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 NSCLCStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MinHee Hong, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277701
- Sponsor's protocol ID
- 4-2021-1595
- Acronym
- LU21-16
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park S, Ahn HK, Lee S, Min YJ, Kim J, Jung HA, Sun JM, Lee SH, Ahn JS, Ahn MJ, Lee JB, Lim SM, Kim HR, Cho BC, Hong MH. Lazertinib for Patients with NSCLC Harboring Uncommon EGFR Mutations: A Phase II Multicenter Trial. J Thorac Oncol. 2025 Sep;20(9):1279-1288. doi: 10.1016/j.jtho.2025.05.006. Epub 2025 May 9.
PubMed 40350080
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations: A Single-arm, Phase II Multi-center Trial
- ClinicalTrials.gov ID
- NCT05277701
- Acronym / sponsor ID
- LU21-16 / 4-2021-1595
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Mar 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 antitumor efficacy of lazertinib in patients with NSCLC harboring uncommon EGFR mutations. The primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a complete response or partial response per RECIST v1.1 by investigator's assessments.Secondary endpoints are disease control rate, progression-free survival, overall survival, and duration of response. Secondary objectives are progression-free survival, overall survival, and safety profile according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- Progression-free survival :From C1D1 to the date of either disease progression or death
- Overall survival: From C1D1 to the date of all-cause mortality
- Safety: Evaluated by NCI-CTCAE v5.0
- The exploratory objective is to identify the acquired resistance mechanism to lazertinib in NSCLC with uncommon EGFR mutation.
Lazertinib 240mg daily (1 cycle of 21 days) will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. However, beyond disease progression is allowed based on the investigator's decision. Doses should be taken approximately 24 hours apart at the same time point each day before eating meal under fasting. If it is more than 12 hours after the dose time, the missed dose should not be taken, and patients should be instructed to take the next dose at the next scheduled time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lazertinib | Experimental | Drug: Lazertinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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).
- Confirmed uncommon EGFR mutations (e.g. G719X, S768I, L861Q, G719X + S768I, G719X + L861Q, L861Q + S768I, L747S, S720A, E709A, exon 18 deletion) without common EGFR mutations including exon 19 deletion, L858R, exon 20 insertion, or T790M. (The result from both cell-free DNA or tissue-based DNA is allowed.)
- Age of 20 or more.
- Performance status of Eastern Cooperative Oncology Group 0 to 2.
- At least one measurable lesion by RECIST 1.1(The part of radiation treatment in the palliative setting is excluded.)
Key exclusion criteria (13 listed)
- Previously treatment with any kind of EGFR TKI
- Uncontrolled central nervous system metastases
- Leptomeningeal carcinomatosis
- Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
- Cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14days of first dose of study treatment, or any investigational drugs within 5 x half-lives of the compound
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 |
|---|---|---|
| LazertinibLazertinib 240mg daily (1 cycle of 21 days) will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. However, beyond disease progression is allowed based on the investigator's decision. Doses should be taken approximately 24 hours apart at the same time point each day before eating meal under fasting. If it is more than 12 hours after the dose time, the missed dose should not be taken, and patients should be instructed to take the next dose at the next scheduled time. | Drug | Lazertinib |
Primary outcome
objective response rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
It is evaluated by taking CT of the chest and abdomen (including liver and adrenal glands) or MRI .
3 secondary outcomes
Progression-free survival(PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Derived from this study: PubMed 40350080Park S, Ahn HK, Lee S, Min YJ, Kim J, Jung HA, Sun JM, Lee SH, Ahn JS, Ahn MJ, Lee JB, Lim SM, Kim HR, Cho BC, Hong MH. Lazertinib for Patients with NSCLC Harboring Uncommon EGFR Mutations: A Phase II Multicenter Trial. J Thorac Oncol. 2025 Sep;20(9):1279-1288. doi: 10.1016/j.jtho.2025.05.006. Epub 2025 May 9.
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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.
MinHee Hong 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 in people with NSCLC, 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 9 inclusion and 13 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 14 Mar 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.
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 MinHee Hong (82-2-2228-8129, MINHEE_HONG@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 NCT05277701, 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 14 Mar 2022.