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Non-small Cell Lung CancerPhase 2NeoLazerNCT06268210

Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer

A Phase 2 study testing Lazertinib+Pemetrexed+Carboplatin and Lazertinib in people with Non-small Cell Lung Cancer, run by Yonsei University at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell… 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+Pemetrexed+Carboplatin and Lazertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSouth Korea
Study dates
7 Feb 2022to Jun 2028
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At the time of providing consent, the patient must be an adult aged 19 years or older.
  • Must have histologically or cytologically confirmed completely resectable, non-squamous non-small cell lung cancer (according to AJCC 8th edition, stages IB-IIIB).
  • Complete surgical resection must be deemed feasible based on the investigator's determination and in accordance with local treatment practices. This decision must be verified through the collaboration of a multidisciplinary team, including surgical oncologists, medical oncologists, and radiation oncologists. (Methods of surgical resection: either lobectomy or segmentectomy)
  • Documented presence of EGFR activating mutations (EGFR exon 19 deletion or L858R mutation).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate and normal organ and bone marrow function, defined as follows:
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  • Hemoglobin: ≥9.0 g/dL Absolute neutrophil count: ≥1.5 × 10^9/L Platelet count: ≥100 × 10^9/L Serum bilirubin: ≤1.5 x upper limit of normal (ULN) ALT and AST: ≤2.5 x ULN Creatinine clearance: ≥50 ml/min or serum creatinine ≤1.5 × ULN
  • Life expectancy of more than 6 months.
  • Female patients must agree to use appropriate contraceptive methods, should not be breastfeeding, and if of childbearing potential, must have evidence of non-pregnancy through a negative pregnancy test prior to initiation. Effective contraception should be maintained for up to 3 months after the last dose of Lazertinib (6 months for Pemetrexed/Carboplatin).
  • Women over 50 years who have discontinued all exogenous hormone therapy and have been amenorrheic for at least 12 months, considered in a "postmenopausal" state.
  • Irreversible surgical infertility due to hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; tubal ligation is not allowed.
  • Women under 50 years should be considered in a postmenopausal state if they have discontinued all exogenous hormone therapy for at least 12 months, with LH and FSH levels within the postmenopausal range per the testing institution's criteria.
  • Male patients who have not undergone vasectomy must agree to barrier contraception, specifically condom use, and effective contraception and sperm donation are prohibited for up to 3 months after the last dose of Lazertinib (6 months for Pemetrexed/Carboplatin).

Who cannot join

  • If there is evidence of locally advanced and/or metastatic disease (Stage IIIC-IV).
  • Known positive status for human immunodeficiency virus (HIV).
  • Evidence of severe or uncontrolled active infections, including chronic active hepatitis B and/or C; patients with chronic hepatitis B virus (HBV) with low viral load (HBV DNA ≤ 500 IU/mL or ≤ 2500 copies/mL) can participate if appropriate antiviral therapy can be continued during the treatment period.
  • Evidence of severe or uncontrolled systemic diseases such as uncontrollable hypertension, active bleeding, etc.
  • History of solid organ transplantation.
  • History of interstitial lung disease (ILD) requiring steroid treatment or clinically active ILD.
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  • History of malignancies other than non-small cell lung cancer within the past 3 years at the time of the first dose of the investigational drug (exceptions: treated cervical intraepithelial neoplasia, differentiated thyroid cancer without lymph node involvement, non-melanoma skin cancer).
  • Intractable nausea and vomiting, gastrointestinal disorders, or patients for whom oral administration is not feasible, and those deemed to have absorption disorders that may interfere with Lazertinib absorption, with the exception of cases where clinically significant absorption disorders are not present, as determined by the investigator, in patients who have undergone colon resection.
  • Pregnant or lactating women.
  • Any of the following cardiac criteria:
  • Average QT interval corrected for heart rate (QTcF) > 470 msec based on three electrocardiogram (ECG) measurements taken with the screening ECG equipment.
  • Clinically significant abnormalities in rhythm, conduction, or morphology at rest on ECG, such as complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 msec.
  • Clinically significant heart failure, congenital long QT syndrome, known concomitant drug administration that prolongs the QT interval, or any factors that increase the risk of QTc prolongation or arrhythmias, such as a family history of QTc prolongation or sudden death under the age of 40.
  • Known hypersensitivity to the active or inactive ingredients of Lazertinib or drugs with a similar chemical structure or belonging to the same class.
  • If, in the investigator's judgment, a patient is unlikely to comply with the clinical trial procedures, restrictions, and requirements, and it is determined that the patient should not participate in the clinical trial.
  • Currently participating or planning to participate in any other interventional clinical trial excluding non-interventional clinical trials.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance hospital

    Seoul

Other trials in South Korea

About this study

Official title: Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer (NeoLazer): a Phase II, Randomized, Multi-center Study

In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations.

Being tested
Lazertinib+Pemetrexed+Carboplatin, 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.

  • Lazertinib+Pemetrexed+CarboplatinDrug

    Lazertinib: 240 mg once daily (pre-/post-surgery for 3 years) Pemetrexed: 500 mg/m2 every 3 weeks (neoadjuvant therapy for 3 cycles) Carboplatin: AUC5 every 3 weeks (neoadjuvant therapy for 3 cycles)

  • LazertinibDrug

    Lazertinib will be administered at a dosage of 240 mg once daily, both before and after surgery, for a duration of 3 years.

Study groups in NCT06268210
Study groupRoleWhat they receive
ExperimentalExperimentalPatients will receive a combination therapy of Lazertinib and Pemed-S + Carboplatin as neoadjuvant treatment before surgery, followed by post-surgery maintenance with Lazertinib at a dosage of 240 mg once daily for a duration of 3 years. Dosages: Lazertinib: 240 mg once daily (pre-/post-surgery for 3 years) Pemetrexed: 500 mg/m2 every 3 weeks (neoadjuvant therapy for 3 cycles) Carboplatin: AUC5 every 3 weeks (neoadjuvant therapy for 3 cycles)
Receives: Drug: Lazertinib+Pemetrexed+Carboplatin
ComparatorActive comparatorLazertinib will be administered at a dosage of 240 mg once daily, both before and after surgery, for a duration of 3 years.
Receives: Drug: Lazertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary pathological response

    Primary pathological response refers to the condition where the proportion of viable tumor cells is defined as 10% or less, indicating a substantial reduction in the survival of tumor cells.

    Measured: After neo adjuvant treatment(3months)

Secondary outcomes (7)

  1. Surgical Resection Methods (Segmentectomy or Lobectomy)

    Surgical techniques defined by thoracic surgeons based on the extent of surgical resection during radical surgery.

    Measured: After radical surgery(3months)

  2. Pathologic Complete Response

    Absence of detectable residual tumors in pathological findings after neoadjuvant therapy.

    Measured: After neo adjuvant treatment(3months)

  3. Objective Response Rate

    Percentage of patients exhibiting complete response (CR) or partial response (PR) based on RECIST 1.1 criteria from radiological examinations performed prior to surgical treatment.

    Measured: After surgery(3months)

  4. Event-Free Survival

    Duration encompassing disease progression in situations where surgical treatment has not been carried out following randomization, excluding disease progression leading to surgical exclusion, disease progression or recurrence post-surgical treatment, or death unrelated to the cause.

    Measured: End of trial(3years)

  5. Disease-Free Survival

    Duration encompassing disease progression, recurrence, or death unrelated to the cause following surgical treatment.

    Measured: End of trial(3years)

  6. Overall Survival

    Duration from randomization to death unrelated to the cause.

    Measured: End of trial(3years)

  7. Number of patients with Adverse events according to CTCAE v5.0

    Evaluation of the safety profile of the protocol treatment summarized in a table for all safety parameters, including:

    • Adverse events according to CTCAE v5.0, including instances leading to treatment interruption, permanent discontinuation, or death.
    • Severe, serious, or specified adverse events.
    • Death.
    • Laboratory parameters, abnormal findings, and vital signs.

    Measured: End of trial(3years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start7 Feb 2022
  3. Primary completionMay 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06268210
Sponsor's protocol ID
4-2023-1546
Acronym
NeoLazer
Status last verified
Jul 2026
First submitted
8 Feb 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lazertinib+Pemetrexed+Carboplatin and Lazertinib 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 13 inclusion and 16 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 7 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?

Primary pathological response (time frame: After neo adjuvant treatment(3months)). 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 NCT06268210.

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 7 Jul 2026.

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