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

  • STATUS
    Recruiting
  • End date
    Jun 11, 2024
  • participants needed
    380
  • sponsor
    Yuhan Corporation
Updated on 11 November 2020
Investigator
Dongmin Kim
Primary Contact
The Townsville Hospital (0.0 mi away) Contact
+76 other location
measurable disease
lung adenocarcinoma
EGFR
gefitinib
stage iv non-small cell lung cancer
lung carcinoma

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
Treatment Gefitinib 250 mg, Lazertinib 240 mg/160 mg, Lazertinib-matching placebo 240 mg/160 mg, Gefitinib-matching placebo 250 mg
Clinical Study IdentifierNCT04248829
SponsorYuhan Corporation
Last Modified on11 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Do you have any of these conditions: Non-Small Cell Lung Cancer or nsclc?
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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