FHND9041 Versus Afatinib for Non-small Cell Lung Cancer

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

August 1, 2021

Primary Completion Date

March 4, 2025

Study Completion Date

May 1, 2025

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

INDUSTRY