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Drug: Furmonertinib

Phase 3

Non-small Cell Lung Carcinoma | Small molecule | Oncology |ArriVent BioPharma, Inc.|Last Updated: Apr 4, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment318
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04853342To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant ChemotherapyPHASE3 RECRUITING 318 — — Jun 7, 2021Jan 1, 2030Apr 4, 20251 China
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Study Endpoints
Primary Endpoints
DFS
From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence). Estimated median time to event of 60 months for those treatment) [ Time Frame: Up to 5 years]

Disease free survival

Secondary Endpoints
Disease free survival (DFS) rate
Time Frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence)Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]
Overall Survival (OS)
Time Frame: From date of randomization until date of death due to any cause Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]
Overall Survival rate at 5 years
Time Frame: From date of randomization until date of death due to any cause about 5years[ Time Frame: Up to 5 years]
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FurmonertinibEXPERIMENTALFurmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.
Placebo FurmonertinibPLACEBO_COMPARATORMatching placebo for Furmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.
Interventions
NameTypeDescription
Drug: Furmonertinib 80 mgDRUGThe initial dose of Furmonertinib 80 mg once daily
Furmonertinib 80 mg placeboDRUGThe initial dose of Furmonertinib 80 mg once daily
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, aged at least 18 years. * Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology. * MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care. * Patients must be c...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04853342studyFirstPostDate: changed