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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
Severance hospital
Seoul, South Korea
RECRUITINGPrimary 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)
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