RecruitingPhase 2NCT06268210

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

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


Sponsor

Yonsei University

Enrollment

160 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a targeted therapy drug called lazertinib (with or without chemotherapy) given before surgery can shrink tumors and improve surgical outcomes in patients with early to mid-stage non-small cell lung cancer that has a specific genetic mutation (EGFR mutation). **You may be eligible if...** - You are 19 or older - You have non-squamous non-small cell lung cancer (Stages IB–IIIB) that is surgically removable - Your tumor has a confirmed EGFR mutation (specifically exon 19 deletion or L858R) - Your overall health is good enough to tolerate surgery and treatment **You may NOT be eligible if...** - Your tumor does not have an EGFR mutation - Your cancer is not surgically removable - You have significant heart, liver, or lung problems that would make surgery unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Severance hospital

Seoul, South Korea

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NCT06268210


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