350
Participants
Start Date
August 1, 2021
Primary Completion Date
March 4, 2025
Study Completion Date
May 1, 2025
FHND9041
FHND9041 is a novel therapeutic agent targeting EGFR mutations. Participants will take an 80 mg oral dose once daily until disease progression, intolerable toxicity, or meeting other study-defined discontinuation criteria.
Afatinib
Afatinib is an approved, second-generation, irreversible EGFR tyrosine kinase inhibitor used as a standard first-line treatment for non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations, such as L858R and Exon 19 deletions. Participants in this arm will take a 40 mg oral dose once daily. Afatinib serves as the active comparator in this study to evaluate the efficacy and safety of FHND9041.
Cancer Hospital Chinese Academy of Medical Sciences, Beijing
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
INDUSTRY