Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
Study NCT ID:
NCT06759857
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-06
First Post:
2024-12-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FHND9041 Versus Afatinib for Non-small Cell Lung Cancer
Sponsor:
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open, Positives Parallel-controlled, Multicenter Phase III to Evaluate the Efficacy and Safety of FHND9041 Versus Afatinib in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FHND9041
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: