drugset / Trial / NCT07458919

Therapy for Advanced NSCLC With EGFR 19delins Mutation

NCT07458919

Phase 0 Not yet recruiting 94 enrolled Fuzhou General Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

In a retrospective analysis of 3,054 advanced NSCLC patients, 41 with EGFR exon 19 deletion-insertions (19delins) received first-generation EGFR TKIs, achieving median PFS of 10.4 months; those with L747\_T751delinsP had notably longer PFS of 18.7 months. Another study of 2,467 treatment-naïve patients found 93 with 19delins treated with first-generation TKIs had median PFS of 19 months, exceeding the 13 months for common 19del mutations. For third-generation TKIs, a study of 215 19delins patients (57 first-line) showed median PFS of 12.9 months, inferior to 23.2 months for common 19del. Our center's retrospective study of 4,666 NSCLC patients in Fujian (2017-2020) included 69 with 19delins: median PFS was 16.7 months with first-generation TKIs versus 7.2 months with third-generation. Evidence suggests specific EGFR deletion locations may affect TKI efficacy; first-generation TKIs may be superior in some 19delins subtypes, while third-generation appear limited. Large prospective data are lacking. This project aims to compare first- versus third-generation EGFR TKIs in 19delins patients via a randomized controlled trial, stratify sensitivity by subtype, and improve survival.

Timeline

Start
2026-03-30
Primary completion
2030-10-30
Completion
2030-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Befotertinib Small molecule 75 mg Oral
Subject Befotertinib Small molecule 100 mg Oral
Subject Firmonertinib Small molecule 80 mg
Subject Gefitinib Small molecule 250 mg
Subject Icotinib Small molecule 125 mg
Subject Osimertinib Small molecule 80 mg

Indications