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FHND9041 Versus Afatinib for Non-small Cell Lung Cancer

NCT06759857 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-01-06

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

  • Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2025-03-04
Completion
2025-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06759857 on ClinicalTrials.gov