Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
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- STATUS
- Recruiting
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- participants needed
- 380
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- sponsor
- Yuhan Corporation
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 | 18-100 years |
| 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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