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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05607550




Registration number
NCT05607550
Ethics application status
Date submitted
31/10/2022
Date registered
7/11/2022
Date last updated
1/10/2024

Titles & IDs
Public title
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)
Scientific title
A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy As First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
Secondary ID [1] 0 0
2022-502977-41-00
Secondary ID [2] 0 0
FURMO-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Non-Small Cell Lung Cancer 0 0
Advanced Non-Small Cell Lung Cancer 0 0
EGFR Exon 20 Mutations 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - furmonertinib 240 mg oral, daily
Treatment: Drugs - furmonertinib 160 mg oral, daily
Treatment: Drugs - platinum-based chemotherapy

Experimental: furmonertinib 240 mg -

Experimental: furmonertinib 160 mg -

Active comparator: platinum-based chemotherapy - carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously


Treatment: Drugs: furmonertinib 240 mg oral, daily
furmonertinib tablet

Treatment: Drugs: furmonertinib 160 mg oral, daily
furmonertinib tablet

Treatment: Drugs: platinum-based chemotherapy
(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) determined by blinded independent central review (BICR)
Timepoint [1] 0 0
Up to 32 months after first dose
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 62 months after first dose
Secondary outcome [2] 0 0
PFS determined by investigator assessment
Timepoint [2] 0 0
Up to 36 months after first dose
Secondary outcome [3] 0 0
Overall response rate (ORR)
Timepoint [3] 0 0
Up to 36 months after first dose
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
Up to 36 months after first dose
Secondary outcome [5] 0 0
Time to second Progression Free Survival (PFS2)
Timepoint [5] 0 0
Up to 36 months after first dose
Secondary outcome [6] 0 0
PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline
Timepoint [6] 0 0
Up to 36 months after first dose
Secondary outcome [7] 0 0
Time to central nervous system (CNS) metastases by BICR
Timepoint [7] 0 0
Randomization up to =30 days after last dose
Secondary outcome [8] 0 0
CNS ORR evaluated by BICR
Timepoint [8] 0 0
Randomization up to =30 days after last dose
Secondary outcome [9] 0 0
CNS DOR evaluated by BICR
Timepoint [9] 0 0
Randomization up to =30 days after last dose
Secondary outcome [10] 0 0
CNS PFS evaluated by BICR
Timepoint [10] 0 0
Randomization up to =30 days after last dose
Secondary outcome [11] 0 0
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
Timepoint [11] 0 0
Randomization up to =30 days after last dose
Secondary outcome [12] 0 0
Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)
Timepoint [12] 0 0
Randomization up to =30 days after last dose
Secondary outcome [13] 0 0
Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)
Timepoint [13] 0 0
Randomization up to =30 days after last dose
Secondary outcome [14] 0 0
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Timepoint [14] 0 0
Up to 36 months after first dose
Secondary outcome [15] 0 0
Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Timepoint [15] 0 0
Up to 36 months after first dose

Eligibility
Key inclusion criteria
Key

* 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 mutation in tumor tissue or blood from local or central testing.
* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
* Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/02/2028
Actual
Sample size
Target
375
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ArriVent Investigative Site - Heidelberg
Recruitment hospital [2] 0 0
Arrivent Investigative Site - Blacktown
Recruitment hospital [3] 0 0
Arrivent Investigative Site - St Leonards
Recruitment hospital [4] 0 0
Arrivent Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
NSW 2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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Alabama
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Jilin
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Lingang Economic and Technological Development Zo
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Pulau Pinang
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Cheras
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Kota Bharu
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Malaysia
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Kuala Lumpur
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Kuching
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Mexico
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Cdmx
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Mexico
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Chiapas
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Netherlands
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Amsterdam
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Netherlands
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Harderwijk
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Philippines
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Cebu
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Philippines
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Davao City
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Philippines
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Manila
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Philippines
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Pasig
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Singapore
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Singapore
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Malaga
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Barcelona
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Madrid
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Spain
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Valencia
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Taiwan
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Chang Hua
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taipei
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Thailand
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Bangkok
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Thailand
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Hat Yai
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United Kingdom
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Surrey
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Wirral
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ArriVent BioPharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Allist Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT05607550
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Morgan Lam
Address 0 0
ArriVent BioPharm
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vanessa Esquibel
Address 0 0
Country 0 0
Phone 0 0
6195403451
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05607550