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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment318

FDA Designations

BREAKTHROUGH_THERAPY

Clinical trial landscape

Drug: Furmonertinib · 1 trial · 1 indication

Phase 3 1
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 ChemotherapyNon-small Cell Lung Carcinoma
RECRUITING318 Analytics
PHASE3RECRUITING
To 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 Chemotherapy
Non-small Cell Lung Carcinoma
NCT04853342318
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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 to 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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Frequently asked questions about Drug: Furmonertinib

What is Furmonertinib used for?

Furmonertinib is an investigational small molecule being studied for the treatment of Non-small Cell Lung Carcinoma. It is currently in Phase 3 clinical development for patients with Epidermal Growth Factor Receptor mutation positive Stage II-IIIA Non-small Cell Lung Carcinoma, following complete tumour resection with or without adjuvant chemotherapy.

What does Furmonertinib target?

Furmonertinib targets the Epidermal Growth Factor Receptor, specifically in patients with Epidermal Growth Factor Receptor mutation positive Non-small Cell Lung Carcinoma. The drug is being evaluated in a biomarker-selected patient population, meaning patients are chosen based on the presence of this specific genetic mutation.

Who is developing Furmonertinib?

Furmonertinib is being developed by ArriVent BioPharma, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol AVBP. The drug is currently in Phase 3 clinical trials for Non-small Cell Lung Carcinoma.

What phase is Furmonertinib in?

Furmonertinib is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug has received Breakthrough Therapy designation from the FDA, which is granted to expedite the development and review of drugs for serious conditions.

What clinical trials is Furmonertinib in?

Furmonertinib is being studied in a Phase 3 clinical trial with the identifier NCT04853342. This randomized, double-blind, placebo-controlled trial is assessing 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. The trial is currently recruiting participants in China.

Is Furmonertinib the same as Furmonertinib 80 mg?

Yes, Furmonertinib 80 mg refers to the same drug, Furmonertinib. The 80 mg designation indicates the specific dosage strength being studied in clinical trials. The drug is being evaluated at this dose in the Phase 3 trial for Non-small Cell Lung Carcinoma.