FHND9041 Versus Afatinib for Non-small Cell Lung Cancer

The goal of this clinical trial is to evaluate the effectiveness and safety of FHND9041 compared to afatinib as first-line treatments for epidermal growth factor receptor mutation-positive (EGFRm+) locally advanced or metastatic non-small cell lung cancer (NSCLC). The main questions it aims to answer are: * Does FHND9041 improve progression-free survival (PFS) compared to afatinib? * Are there differences in safety profiles between FHND9041 and afatinib? Researchers will compare FHND9041 (80 mg, orally, once daily) with afatinib (40 mg, orally, once daily) in a randomized, open-label, parallel-controlled, multicenter Phase III trial. Participants who meet the inclusion criteria, including having EGFR mutations (L858R and/or Exon 19 deletion) and no prior treatment, will be randomly assigned in a 1:1 ratio to either the FHND9041 group or the afatinib group. Treatment will continue until disease progression, intolerable drug-related toxicity, or other pre-specified treatment discontinuation criteria are met. Study Procedures: Participants will: * Be screened for eligibility and randomly assigned to one of two groups. * Receive study drugs per their assigned group. * Undergo regular tumor assessments by Response Evaluation Criteria in Solid Tumors, version 1.1( RECIST 1.1) every six weeks during the first 18 cycles, then every nine weeks until disease progression. For intracranial efficacy, Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM ) criteria will be applied. * Participate in pharmacokinetic studies (FHND9041 group only) with blood samples collected pre-dose at specified cycles and on the day of discontinuation. After disease progression, participants will be followed for survival every three months.

NCT Number	NCT06759857
Lead Sponsor	Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Conditions	Non Small Cell Lung Cancer
Enrollment	350 participants
Start Date	2021-08-01
Primary Completion	2025-03-04 (estimated)
Study Completion	2025-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-01-06