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furmonertinib, daily

Phase 3

Metastatic Non-Small Cell Lung Cancer | Small molecule | Oncology |ArriVent BioPharma, Inc.|Last Updated: Jun 22, 2025

Target and mechanism

Target class-Tinib (Kinase)
ModalitySmall molecule

Also known as Furmonertinib, Furmonertinib 160mg, Drug: Furmonertinib

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment398

FDA Designations

BREAKTHROUGH_THERAPY

Clinical trial landscape

furmonertinib, daily · 1 trial · 3 indications

Phase 3 1
NCT05607550Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)Metastatic Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING398 Analytics
PHASE3ACTIVE NOT_RECRUITING
Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
Metastatic Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS) determined by blinded independent central review (BICR)
Up to 32 months after first dose

Secondary Endpoints

Overall Survival (OS)
Up to 62 months after first dose
PFS determined by investigator assessment
Up to 36 months after first dose
Overall response rate (ORR)
Up to 36 months after first dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
furmonertinib 240 mgEXPERIMENTAL -
furmonertinib 160 mgEXPERIMENTAL -
platinum-based chemotherapyACTIVE_COMPARATORcarboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

Interventions

NameTypeDescription
furmonertinib 240 mg oral, dailyDRUGfurmonertinib tablet
furmonertinib 160 mg oral, dailyDRUGfurmonertinib tablet
platinum-based chemotherapyDRUG(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites208

Key Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. * Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion...

Countries:United StatesAustraliaBrazilCanadaChinaFranceIsraelItalyJapanMalaysiaMexicoNetherlandsPhilippinesSingaporeSouth KoreaSpainTaiwanThailandUnited Kingdom
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Metastatic Non-Small Cell Lung Cancer")

Frequently asked questions about furmonertinib, daily

What is Furmonertinib used for?

Furmonertinib is an investigational small molecule being developed for non-small cell lung cancer (NSCLC), including metastatic disease. It is studied in patients with EGFR exon 20 insertion mutations and in advanced EGFR mutant NSCLC with uncleared ctDNA. It is not yet approved and remains in clinical development.

What does Furmonertinib target?

Furmonertinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is being studied in NSCLC patients with EGFR exon 20 insertion mutations, suggesting it targets the epidermal growth factor receptor (EGFR) pathway. The drug is administered orally at doses including 80 mg, 160 mg, and 240 mg daily.

Who makes Furmonertinib?

Furmonertinib is being developed by ArriVent BioPharma, Inc., a biopharmaceutical company traded under the ticker AVBP. The company is conducting clinical trials for this investigational drug in non-small cell lung cancer.

What phase is Furmonertinib in?

Furmonertinib is in Phase 2 clinical development, with active trials including a Phase 2 study in advanced EGFR mutant NSCLC. It has received Breakthrough Therapy designation from the FDA. The drug is investigational and has not been approved for any use.

What clinical trials is Furmonertinib in?

Furmonertinib is being studied in several trials, including NCT04858958 (Phase 1, NSCLC with exon 20 insertion), NCT05334277 (Phase 2, EGFR mutant NSCLC with uncleared ctDNA), NCT05466149 (Phase 2, NSCLC with EGFR exon 20 insertion), and NCT05607550 (Phase 3, FURVENT, comparing to chemotherapy in metastatic NSCLC).

Is Furmonertinib the same as other names?

Furmonertinib is also known by its dosage forms, including Furmonertinib 80 mg, 160 mg, and 240 mg oral daily. These names refer to the same drug compound. No other alternative names have been disclosed.