Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）

Phase 3 Active not recruiting 358 enrolled Allist Pharmaceuticals, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

To assess the efficacy and safety of Alflutinib Mesylate versus Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Timeline

Start: 2019-05-30
Primary completion: 2021-09-15
Completion: 2026-03

Outcome

Met primary endpoint

paper Median IRC-assessed progression-free survival was 20·8 months (95% CI 17·8-23·5) in the furmonertinib group and 11·1 months (9·7-12·5) in the gefitinib group PMID 35662408 ↗

paper hazard ratio 0·44, 95% CI 0·34-0·58; p<0·0001 PMID 35662408 ↗

Publications

Shi Y, Chen G, Wang X, Liu Y, Wu L, Hao Y, Liu C, Zhu S, Zhang X, Li Y, Liu J, Cao L, Cheng Y, Zhao H, Zhang S, Zang A, Cui J, Feng J, Yang N, Liu F, Jiang Y, Gu C; FURLONG investigators. Furmonertinib (AST2818) versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (FURLONG): a multicentre, double-blind, randomised phase 3 study. Lancet Respir Med. 2022 Nov;10(11):1019-1028. doi: 10.1016/S2213-2600(22)00168-0. Epub 2022 Jun 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Firmonertinib	Small molecule	80 mg	Oral
Comparator	Gefitinib	Small molecule	250 mg	Oral

Indications

No indication recorded.