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)

NCT ID: NCT05607550

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2028-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer EGFR Exon 20 Mutations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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furmonertinib 240 mg

Group Type EXPERIMENTAL

furmonertinib 240 mg oral, daily

Intervention Type DRUG

furmonertinib tablet

furmonertinib 160 mg

Group Type EXPERIMENTAL

furmonertinib 160 mg oral, daily

Intervention Type DRUG

furmonertinib tablet

platinum-based chemotherapy

carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

Group Type ACTIVE_COMPARATOR

platinum-based chemotherapy

Intervention Type DRUG

(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Interventions

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furmonertinib 240 mg oral, daily

furmonertinib tablet

Intervention Type DRUG

furmonertinib 160 mg oral, daily

furmonertinib tablet

Intervention Type DRUG

platinum-based chemotherapy

(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Intervention Type DRUG

Other Intervention Names

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AST2818 AST2818

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allist Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

ArriVent BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morgan Lam

Role: STUDY_DIRECTOR

ArriVent BioPharm

Locations

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Arrivent Investigative Site

Daphne, Alabama, United States

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Yuma, Arizona, United States

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Fayetteville, Arkansas, United States

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Beverly Hills, California, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Los Alamitos, California, United States

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Napa, California, United States

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Orange, California, United States

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Orange, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Santa Monica, California, United States

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Santa Rosa, California, United States

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Whittier, California, United States

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Hartford, Connecticut, United States

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Norwich, Connecticut, United States

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Fort Myers, Florida, United States

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St. Petersburg, Florida, United States

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The Villages, Florida, United States

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Peoria, Illinois, United States

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Rolling Meadows, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Bethesda, Maryland, United States

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Frederick, Maryland, United States

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Rockville, Maryland, United States

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Fairhaven, Massachusetts, United States

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Lansing, Michigan, United States

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Bolivar, Missouri, United States

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Kansas City, Missouri, United States

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Saint Joseph, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Belleville, New Jersey, United States

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Englewood, New Jersey, United States

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Florham Park, New Jersey, United States

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The Bronx, New York, United States

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Goldsboro, North Carolina, United States

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Pinehurst, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Salem, Oregon, United States

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Gettysburg, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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York, Pennsylvania, United States

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Greenville, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Abilene, Texas, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Fredericksburg, Virginia, United States

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Bellingham, Washington, United States

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Spokane Valley, Washington, United States

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Tacoma, Washington, United States

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Appleton, Wisconsin, United States

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Heidelberg, Victoria, Australia

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Blacktown, , Australia

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St Leonards, , Australia

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Woolloongabba, , Australia

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Salvador, Estado de Bahia, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Pelotas, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande, Brazil

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Blumenau, SC Cep, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Liberdade, São Paulo/SP, Brazil

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Taubaté, Taubate SP, Brazil

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Porto Alegre, , Brazil

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Beijing, Beijing Municipality, China

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Meizhou, Guangdong, China

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Xuhui, Hai City, China

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Hangzhou, Hangzhou, China

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Cangzhou, Hebei, China

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Shushan, Hefei, China

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Zhengzhou, Henan, China

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Changchun, Jilin, China

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Weihai, Lingang Economic and Technological Development Zo, China

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Nanning, Nanning, China

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Yangpu, Shanghai Municipality, China

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Xi’an, Shanxi, China

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Taiyuan, Taiyuan, China

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Kunming, Yunnan, China

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Zhejiang, Zhejiang, China

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Anyang, , China

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Changchun, , China

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Changsha, , China

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Changsha, , China

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Chengdu, , China

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Chenzhou, , China

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Chongqing, , China

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Guangzhou, , China

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Guangzhou, , China

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Harbin, , China

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Hefei, , China

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Huai'an, , China

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Huizhou, , China

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Jinan, , China

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Jinan, , China

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Jining, , China

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Lanzhou, , China

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Lishui, , China

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Luoyang, , China

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Nanchang, , China

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Nanchang, , China

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Nanjing, , China

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Ningbo, , China

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Shanghai, , China

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Shantou, , China

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Shenyang, , China

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Shenzhen, , China

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Taiyuan, , China

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Tianjin, , China

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Weihui, , China

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Wuhan, , China

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Xiamen, , China

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Xianyang, , China

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Xinxiang, , China

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Xuzhou, , China

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Zhengzhou, , China

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Caen, , France

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Lyon, , France

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Lyon, , France

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Marseille, , France

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Toulouse, , France

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Villejuif, , France

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Beersheba, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Rozzano, Milan, Italy

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Aviano, PN, Italy

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Roma, Rome, Italy

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Bari, , Italy

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Meldola, , Italy

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Milan, , Italy

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Kurume, Fukuoka, Japan

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Akashi, , Japan

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Hirakata, , Japan

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Kashiwa, , Japan

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Nagoya, , Japan

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Ōsaka-sayama, , Japan

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Sapporo, , Japan

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Sendai, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Ube, , Japan

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Yokohama, , Japan

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George Town, Pulau Pinang, Malaysia

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Cheras, , Malaysia

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Kota Bharu, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuching, , Malaysia

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Tuxtla Gutiérrez, Chiapas, Mexico

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Mexico City, Mexico City, Mexico

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Amsterdam, , Netherlands

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Harderwijk, , Netherlands

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Cebu, , Philippines

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Davao City, , Philippines

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Manila, , Philippines

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Pasig, , Philippines

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Singapore, , Singapore

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Singapore, , Singapore

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Jungni I Gu, Seoul, South Korea

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Busan, , South Korea

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Hwasun, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Málaga, Malaga, Spain

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A Coruña, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Chang-hua, , Taiwan

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Kaohsiung City, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Hat Yai, , Thailand

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Guildford, Surrey, United Kingdom

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Bebington, Wirral, United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Sutton, , United Kingdom

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Countries

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United States Australia Brazil Canada China France Israel Italy Japan Malaysia Mexico Netherlands Philippines Singapore South Korea Spain Taiwan Thailand United Kingdom

Other Identifiers

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2022-502977-41-00

Identifier Type: CTIS

Identifier Source: secondary_id

FURMO-004

Identifier Type: -

Identifier Source: org_study_id

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