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A Randomized, Double-blind, Positive-controlled, Multi-center Phase III Clinical Study of Evaluating Alflutinib Mesylate Versus Gefitinib as First-line Therapy in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) With EGFR-sensitive Mutations（FlAG）
To assess the efficacy and safety of Alflutinib Mesylate versus Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
Details
| Lead sponsor | Allist Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 358 |
| Start date | 2019-05-30 |
| Completion | 2026-03 |
Conditions
- Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer
Interventions
- Alflutinib Mesylate (AST2818) 80mg//40 mg+ placebo
- Placebo Gefitinib 250 mg
- Gefitinib 250 mg
- Placebo AST2818 80mg//40 mg
Primary outcomes
- Median Progression Free Survival (PFS) (Months) — At baseline and every 6 weeks for the first 17 months and then every 12 weeks relative to randomisation until progression ( (approximately 12 months)
Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent alflutinib compared with SoC EGFR-TKI therapy as measured by PFS.
Countries
China