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A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib Versus Gefitinib as the First-line Treatment in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
Details
| Lead sponsor | Yuhan Corporation |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 393 |
| Start date | 2020-02-13 |
| Completion | 2026-06 |
Conditions
- Non-Small Cell Lung Cancer
Interventions
- Lazertinib 240 mg/160 mg
- Gefitinib 250 mg
- Lazertinib-matching placebo 240 mg/160 mg
- Gefitinib-matching placebo 250 mg
Primary outcomes
- Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment — At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.
PFS was defined as the time from randomization until the date of objective progression or death(by any cause whichever comes first based on investigator assessment using RECIST v1.1 and was used to assess the efficacy of lazertinib compared to the gefitinib).
Countries
Australia, Greece, Hungary, Malaysia, Philippines, Russia, Serbia, Singapore, South Korea, Taiwan, Thailand, Turkey (Türkiye), Ukraine