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Active, not recruitingNCT06268210NeoLazerUpdated Jul 7, 2026

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

A Phase 2 interventional study of Lazertinib+Pemetrexed+Carboplatin and Lazertinib in Non-small Cell Lung Cancer, sponsored by Yonsei University. Active, not recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Yonsei University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Feb 2022, registered Feb 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Non-small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 160 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. At the time of providing consent, the patient must be an adult aged 19 years or older.
  2. Must have histologically or cytologically confirmed completely resectable, non-squamous non-small cell lung cancer (according to AJCC 8th edition, stages IB-IIIB).
  3. 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)
  4. Documented presence of EGFR activating mutations (EGFR exon 19 deletion or L858R mutation).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Adequate and normal organ and bone marrow function, defined as follows:

    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

  7. Life expectancy of more than 6 months.
  8. 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.

  9. 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).

Exclusion criteria

Exclusion Criteria:

  1. If there is evidence of locally advanced and/or metastatic disease (Stage IIIC-IV).
  2. Known positive status for human immunodeficiency virus (HIV).
  3. 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.
  4. Evidence of severe or uncontrolled systemic diseases such as uncontrollable hypertension, active bleeding, etc.
  5. History of solid organ transplantation.
  6. History of interstitial lung disease (ILD) requiring steroid treatment or clinically active ILD.
  7. 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).
  8. 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.
  9. Pregnant or lactating women.
  10. 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.

  11. Known hypersensitivity to the active or inactive ingredients of Lazertinib or drugs with a similar chemical structure or belonging to the same class.
  12. 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.
  13. Currently participating or planning to participate in any other interventional clinical trial excluding non-interventional clinical trials.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Experimental

    Patients 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)

    Drug: Lazertinib+Pemetrexed+Carboplatin

  • Active comparator
    Comparator

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

    Drug: Lazertinib

Interventions

  • DrugLazertinib+Pemetrexed+Carboplatin

    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)

  • DrugLazertinib

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

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What researchers measure

Primary outcomes

  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.

    Time frame: After neo adjuvant treatment(3months)

Secondary outcomes

  1. Surgical Resection Methods (Segmentectomy or Lobectomy)

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

    Time frame: After radical surgery(3months)

  2. Pathologic Complete Response

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

    Time frame: 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.

    Time frame: 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.

    Time frame: End of trial(3years)

  5. Disease-Free Survival

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

    Time frame: End of trial(3years)

  6. Overall Survival

    Duration from randomization to death unrelated to the cause.

    Time frame: 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.

    Time frame: End of trial(3years)

07

Study locations

1 site
  • Severance hospital
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06268210
Lead sponsor
Yonsei University
Responsible party
Chang Gon Kim (Principal Investigator, Yonsei University) — Principal investigator
First posted
Feb 20, 2024
Start date
Feb 7, 2022
Primary completion
May 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Jul 7, 2026

Study contacts

Hye Ryun Kim
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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