Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

STATUS

Recruiting
participants needed

380
sponsor

Yuhan Corporation

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Updated on 19 February 2024

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measurable disease

adenocarcinoma

gefitinib

stage iv non-small cell lung cancer

curative surgery

lung adenocarcinoma

EGFR

small cell lung cancer

lazertinib

Summary

This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations

Description

YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR.

This is a Phase III, Randomized, Double-blind study evaluating the efficacy and safety of YH25448 (240 mg orally, once daily) versus Gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitizing mutation (EGFRm) positive, treatment-nave and eligible for first-line treatment with an EGFR-TKI.

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer
Age	18years - 100years
Treatment	Lazertinib 240 mg/160 mg, Gefitinib 250 mg, Lazertinib-matching placebo 240 mg/160 mg, Gefitinib-matching placebo 250 mg
Clinical Study Identifier	NCT04248829
Sponsor	Yuhan Corporation
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Pathologically confirmed adenocarcinoma of the lung
	Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
	At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
	Treatment-nave for locally advanced or metastatic NSCLC
	WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
	At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period
Exclusion Criteria
	Symptomatic and unstable brain metastases
	Leptomeningeal metastases
	Symptomatic spinal cord compression
	History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
	Any medical conditions requiring chronic continuous oxygen therapy
	History of any malignancy other than the disease under study within 3 years before randomization
	Any cardiovascular disease as follows
	History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment
	History of myocardial infarction or unstable angina within 24 weeks of randomization

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Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)