Clinical trial NCT05607550: 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Non-Small Cell Lung Cancer
Advanced Non-Small Cell Lung Cancer
EGFR Exon 20 Mutations
Keywords: Non-Small Cell Lung Cancer (NSCLC)
Exon 20
Furmonertinib
Firmonertinib
AST2818
FURMO-004
Drug-Therapy
Lead sponsor: ArriVent BioPharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Allist Pharmaceuticals, Inc.
First posted: 2022-11-07
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

Primary outcomes:
measure: Progression Free Survival (PFS) determined by blinded independent central review (BICR)
timeFrame: Up to 32 months after first dose
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 62 months after first dose
measure: PFS determined by investigator assessment
timeFrame: Up to 36 months after first dose
measure: Overall response rate (ORR)
timeFrame: Up to 36 months after first dose
measure: Duration of response (DOR)
timeFrame: Up to 36 months after first dose
measure: Time to second Progression Free Survival (PFS2)
timeFrame: Up to 36 months after first dose
measure: PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline
timeFrame: Up to 36 months after first dose
measure: Time to central nervous system (CNS) metastases by BICR
timeFrame: Randomization up to ≤30 days after last dose
measure: CNS ORR evaluated by BICR
timeFrame: Randomization up to ≤30 days after last dose
measure: CNS DOR evaluated by BICR
timeFrame: Randomization up to ≤30 days after last dose
measure: CNS PFS evaluated by BICR
timeFrame: Randomization up to ≤30 days after last dose
measure: Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
timeFrame: Randomization up to ≤30 days after last dose
measure: Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)
timeFrame: Randomization up to ≤30 days after last dose
measure: Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)
timeFrame: Randomization up to ≤30 days after last dose
measure: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
timeFrame: Up to 36 months after first dose
measure: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
timeFrame: Up to 36 months after first dose
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Arrivent Investigative Site
state: Alabama
city: Yuma
country: United States
facility: Arrivent Investigative Site
state: Arizona
city: Fayetteville
country: United States
facility: Arrivent Investigative Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Arrivent Investigative Site
state: California
city: Fullerton
country: United States
facility: Arrivent Investigative Site
state: California
city: Long Beach
country: United States
facility: Arrivent Investigative Site
state: California
city: Los Alamitos
country: United States
facility: Arrivent Investigative Site
state: California
city: Napa
country: United States
facility: Arrivent Investigative Site
state: California
city: Orange
country: United States
facility: Arrivent Investigative Site
state: California
city: Orange
country: United States
facility: Arrivent Investigative Site
state: California
city: Sacramento
country: United States
facility: Arrivent Investigative site
state: California
city: San Diego
country: United States
facility: Arrivent Investigative Site
state: California
city: Santa Barbara
country: United States
facility: Arrivent Investigative Site
state: California
city: Santa Monica
country: United States
facility: Arrivent Investigative Site
state: California
city: Santa Rosa
country: United States
facility: Arrivent Investigative Site
state: California
city: Whittier
country: United States
facility: Arrivent Investigative Site
state: California
city: Hartford
country: United States
facility: Arrivent Investigative Site
state: Connecticut
city: Norwich
country: United States
facility: Arrivent Investigative Site
state: Connecticut
city: Fort Myers
country: United States
facility: Arrivent Investigative Site
state: Florida
city: Saint Petersburg
country: United States
facility: Arrivent Investigative Site
state: Florida
city: The Villages
country: United States
facility: Arrivent Investigative Site
state: Florida
city: Peoria
country: United States
facility: Arrivent Investigative Site
state: Illinois
city: Rolling Meadows
country: United States
facility: Arrivent Investigative Site
state: Illinois
city: Fort Wayne
country: United States
facility: Arrivent Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Arrivent Investigative Site
state: Indiana
city: South Bend
country: United States
facility: Arrivent Investigative Site
state: Indiana
city: Bethesda
country: United States
facility: Arrivent Investigative Site
state: Maryland
city: Frederick
country: United States
facility: Arrivent Investigative Site
state: Maryland
city: Rockville
country: United States
facility: Arrivent Investigative Site
state: Maryland
city: Fairhaven
country: United States
facility: Arrivent Investigative Site
state: Massachusetts
city: Lansing
country: United States
facility: Arrivent Investigative Site
state: Michigan
city: Bolivar
country: United States
facility: Arrivent Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: Arrivent Investigative Site
state: Missouri
city: Saint Joseph
country: United States
facility: Arrivent Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Arrivent Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Arrivent Investigative Site
state: Nebraska
city: Belleville
country: United States
facility: Arrivent Investigative Site
state: New Jersey
city: Englewood
country: United States
facility: Arrivent Investigative Site
state: New Jersey
city: Florham Park
country: United States
facility: Arrivent Investigative Site
state: New Jersey
city: Bronx
country: United States
facility: Arrivent Investigative Site
state: New York
city: Goldsboro
country: United States
facility: Arrivent Investigative Site
state: North Carolina
city: Pinehurst
country: United States
facility: ArriVent Investigative Site
state: North Carolina
city: Canton
country: United States
facility: Arrivent Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Arrivent Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: ArriVent Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Arrivent Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Arrivent Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Arrivent Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Arrivent Investigative Site
state: Oklahoma
city: Salem
country: United States
facility: Arrivent Investigative Site
state: Oregon
city: Gettysburg
country: United States
facility: Arrivent Investigative Site
state: Pennsylvania
city: Langhorne
country: United States
facility: ArriVent Investigative Site
state: Pennsylvania
city: York
country: United States
facility: Arrivent Investigative Site
state: Pennsylvania
city: Greenville
country: United States
facility: Arrivent Investigative Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Arrivent Investigative Site
state: South Dakota
city: Memphis
country: United States
facility: Arrivent Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: ArriVent Investigative Site
state: Tennessee
city: Abilene
country: United States
facility: Arrivent Investigative Site
state: Texas
city: Austin
country: United States
facility: ArriVent Investigative Site
state: Texas
city: Houston
country: United States
facility: Arrivent Investigative Site
state: Texas
city: Plano
country: United States
facility: Arrivent Investigative Site
state: Texas
city: Ogden
country: United States
facility: Arrivent Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Arrivent Investigative Site
state: Utah
city: Fairfax
country: United States
facility: ArriVent Investigative Site
state: Virginia
city: Fredericksburg
country: United States
facility: Arrivent Investigative Site
state: Virginia
city: Bellingham
country: United States
facility: Arrivent Investigative Site
state: Washington
city: Spokane Valley
country: United States
facility: Arrivent Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Arrivent Investigative Site
state: Washington
city: Appleton
country: United States
facility: Arrivent Investigative Site
state: Wisconsin
city: Heidelberg
country: Australia
facility: ArriVent Investigative Site
state: Victoria
city: Blacktown
country: Australia
facility: Arrivent Investigative Site
city: St Leonards
country: Australia
facility: Arrivent Investigative Site
city: Woolloongabba
country: Australia
facility: Arrivent Investigative Site
city: Salvador
country: Brazil
facility: ArriVent Investigative Site
state: Bahia
city: Belo Horizonte
country: Brazil
facility: ArriVent Investigative Site
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: ArriVent Investigative Site
state: Rio Grande
city: Rio De Janeiro
country: Brazil
facility: ArriVent Investigative Site
state: RJ
city: Rio De Janeiro
country: Brazil
facility: ArriVent Investigative Site
state: RJ
city: Pelotas
country: Brazil
facility: ArriVent Investigative Site
state: RS
city: São José Do Rio Preto
country: Brazil
facility: ArriVent Investigative Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: ArriVent Investigative Site
state: Sao Paulo
city: Blumenau
country: Brazil
facility: ArriVent Investigative Site
state: SC Cep
city: Liberdade
country: Brazil
facility: ArriVent Investigative Site
state: São Paulo/SP
city: Taubaté
country: Brazil
facility: ArriVent Investigative Site
state: Taubate SP
city: Porto Alegre
country: Brazil
facility: ArriVent Investigative Site
city: Edmonton
country: Canada
facility: ArriVent Investigative Site
state: Alberta
city: Toronto
country: Canada
facility: ArriVent Investigative Site
state: Ontario
city: Beijing
country: China
facility: Allist Investigative Site
state: Beijing
city: Meizhou City
country: China
facility: Allist Investigative Site
state: Guangdong
city: Xuhui
country: China
facility: Allist Investigative Site
state: Hai City
city: Hangzhou
country: China
facility: Allist Investigative Site
state: Hangzhou
city: Cangzhou
country: China
facility: Allist Investigative Site
state: Hebei
city: Shushan
country: China
facility: Allist Investigative Site
state: Hefei
city: Zhengzhou
country: China
facility: Allist Investigative Site
state: Henan
city: Changchun
country: China
facility: Allist Investigative Site
state: Jilin
city: Weihai
country: China
facility: Allist Investigative Site
state: Lingang Economic And Technological Development Zo
city: Nanning
country: China
facility: Allist Investigative Site
state: Nanning
city: Yangpu
country: China
facility: Allist Investigative Site
state: Shanghai
city: Xi'an
country: China
facility: Allist Investigative Site
state: Shanxi
city: Taiyuan
country: China
facility: Allist Investigative Site
state: Taiyuan
city: Kunming
country: China
facility: Allist Investigative Site
state: Yunnan
city: Zhejiang
country: China
facility: Allist Investigative Site
state: Zhejiang
city: Anyang
country: China
facility: Allist Investigative Site
city: Changchun
country: China
facility: Allist Investigative Site
city: Changsha
country: China
facility: Allist Investigative Site
city: Changsha
country: China
facility: Allist Investigative Site
city: Chengdu
country: China
facility: Allist Investigative Site
city: Chenzhou
country: China
facility: Allist Investigative Site
city: Chongqing
country: China
facility: Allist Investigative Site
city: Guangzhou
country: China
facility: Allist Investigative Site
city: Guangzhou
country: China
facility: Allist Investigative Site
city: Harbin
country: China
facility: Allist Investigative Site
city: Hefei
country: China
facility: Allist Investigative Site
city: Huai'an
country: China
facility: Allist Investigative Site
city: Huizhou
country: China
facility: Allist Investigative Site
city: Jinan
country: China
facility: Allist Investigative Site
city: Jinan
country: China
facility: Allist Investigative Site
city: Jining
country: China
facility: Allist Investigative Site
city: Lanzhou
country: China
facility: Allist Investigative Site
city: Lishui
country: China
facility: Allist Investigative Site
city: Luoyang
country: China
facility: Allist Investigative Site
city: Nanchang
country: China
facility: Allist Investigative Site
city: Nanchang
country: China
facility: Allist Investigative Site
city: Nanjing
country: China
facility: Allist Investigative Site
city: Ningbo
country: China
facility: Allist Investigative Site
city: Shanghai
country: China
facility: Allist Investigative Site
city: Shantou
country: China
facility: Allist Investigative Site
city: Shenyang
country: China
facility: Allist Investigative Site
city: Shenzhen
country: China
facility: Allist Investigative Site
city: Taiyuan
country: China
facility: Allist Investigative Site
city: Tianjin
country: China
facility: Allist Investigative Site
city: Weihui
country: China
facility: Allist Investigative Site
city: Wuhan
country: China
facility: Allist Investigative Site
city: Xiamen
country: China
facility: Allist Investigative Site
city: Xianyang
country: China
facility: Allist Investigative Site
city: Xinxiang
country: China
facility: Allist Investigative Site
city: Xuzhou
country: China
facility: Allist Investigative Site
city: Zhengzhou
country: China
facility: Allist Investigative Site
city: Caen
country: France
facility: Arrivent Investigative Site
city: Lyon
country: France
facility: Arrivent Investigative Site
city: Lyon
country: France
facility: Arrivent Investigative Site
city: Marseille
country: France
facility: Arrivent Investigative Site
city: Toulouse
country: France
facility: Arrivent Investigative Site
city: Villejuif
country: France
facility: Arrivent Investigative Site
city: Be'er Sheva
country: Israel
facility: ArriVent Investigative Site
city: Haifa
country: Israel
facility: ArriVent Investigative Site
city: Jerusalem
country: Israel
facility: ArriVent Investigative Site
city: Rozzano
country: Italy
facility: ArriVent Investigative Site
state: Milan
city: Aviano
country: Italy
facility: ArriVent Investigative Site
state: PN
city: Roma
country: Italy
facility: ArriVent Investigative Site
state: Rome
city: Bari
country: Italy
facility: ArriVent Investigative Site
city: Meldola
country: Italy
facility: Arrivent Investigative Site
city: Milano
country: Italy
facility: ArriVent Investigative Site
city: Kurume
country: Japan
facility: ArriVent Investigative Site
state: Fukuoka
city: Akashi
country: Japan
facility: Arrivent Investigative Site
city: Hirakata
country: Japan
facility: Arrivent Investigative Site
city: Kashiwa
country: Japan
facility: Arrivent Investigative Site
city: Nagoya
country: Japan
facility: Arrivent Investigative Site
city: Sapporo-shi
country: Japan
facility: Arrivent Investigative Site
city: Sendai
country: Japan
facility: Arrivent Investigative Site
city: Shizuoka
country: Japan
facility: Arrivent Investigative Site
city: Tokyo
country: Japan
facility: Arrivent Investigative Site
city: Tokyo
country: Japan
facility: ArriVent Investigative Site
city: Ube
country: Japan
facility: Arrivent Investigative Site
city: Yokohama
country: Japan
facility: Arrivent Investigative Site
city: Ōsaka-sayama
country: Japan
facility: Arrivent Investigative Site
city: Jungni I Gu
country: Korea, Republic of
facility: ArriVent Investigative Site
state: Seoul
city: Busan
country: Korea, Republic of
facility: Arrivent Investigative Site
city: Hwasun
country: Korea, Republic of
facility: Arrivent Investigative Site
city: Seoul
country: Korea, Republic of
facility: Arrivent Investigative Site
city: Seoul
country: Korea, Republic of
facility: Arrivent Investigative Site
city: Seoul
country: Korea, Republic of
facility: Arrivent Investigative Site
city: Seoul
country: Korea, Republic of
facility: Arrivent Investigative Site
city: George Town
country: Malaysia
facility: ArriVent Investigative Site
state: Pulau Pinang
city: Cheras
country: Malaysia
facility: Arrivent Investigative Site
city: Kota Bharu
country: Malaysia
facility: Arrivent Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Arrivent Investigative Site
city: Kuching
country: Malaysia
facility: Arrivent Investigative Site
city: Ciudad de mexico
country: Mexico
facility: ArriVent Investigative Site
state: Cdmx
city: Tuxtla Gutiérrez
country: Mexico
facility: ArriVent Investigative Site
state: Chiapas
city: Amsterdam
country: Netherlands
facility: Arrivent Investigative Site
city: Harderwijk
country: Netherlands
facility: Arrivent Investigative Site
city: Cebu
country: Philippines
facility: Arrivent Investigative Site
city: Davao City
country: Philippines
facility: Arrivent Investigative Site
city: Manila
country: Philippines
facility: ArriVent Investigative Site
city: Pasig
country: Philippines
facility: Arrivent Investigative Site
city: Singapore
country: Singapore
facility: ArriVent Investigative Site
city: Singapore
country: Singapore
facility: Arrivent Investigative Site
city: Málaga
country: Spain
facility: ArriVent Investigative Site
state: Malaga
city: A Coruña
country: Spain
facility: Arrivent Investigative Site
city: Barcelona
country: Spain
facility: Arrivent Investigative Site
city: Madrid
country: Spain
facility: ArriVent Investigative Site
city: Valencia
country: Spain
facility: Arrivent Investigative Site
city: Chang Hua
country: Taiwan
facility: Arrivent Investigative Site
city: Kaohsiung
country: Taiwan
facility: Arrivent Investigative Site
city: Kaohsiung
country: Taiwan
facility: ArriVent Investigative Site
city: Taichung
country: Taiwan
facility: ArriVent Investigative Site
city: Tainan
country: Taiwan
facility: Arrivent Investigative Site
city: Taipei
country: Taiwan
facility: Arrivent Investigative Site
city: Bangkok
country: Thailand
facility: Arrivent Investigative Site
city: Bangkok
country: Thailand
facility: Arrivent Investigative Site
city: Bangkok
country: Thailand
facility: Arrivent Investigative Site
city: Hat Yai
country: Thailand
facility: Arrivent Investigative Site
city: Guildford
country: United Kingdom
facility: ArriVent Investigative Site
state: Surrey
city: Bebington
country: United Kingdom
facility: Arrivent Investigative Site
state: Wirral
city: London
country: United Kingdom
facility: ArriVent Investigative Site
city: Manchester
country: United Kingdom
facility: ArriVent Investigative Site
city: Sutton
country: United Kingdom
facility: ArriVent Investigative Site
Study officials:
affiliation: ArriVent BioPharm
name: Morgan Lam
role: STUDY_DIRECTOR
References: