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
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.
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 →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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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
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.
Exclusion Criteria:
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.
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
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
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)
Lazertinib will be administered at a dosage of 240 mg once daily, both before and after surgery, for a duration of 3 years.
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)
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)
Pathologic Complete Response
Absence of detectable residual tumors in pathological findings after neoadjuvant therapy.
Time frame: After neo adjuvant treatment(3months)
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)
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)
Disease-Free Survival
Duration encompassing disease progression, recurrence, or death unrelated to the cause following surgical treatment.
Time frame: End of trial(3years)
Overall Survival
Duration from randomization to death unrelated to the cause.
Time frame: End of trial(3years)
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)
Plan to share: No
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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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Carcinoma, Non-Small-Cell Lung→
Yonsei University