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)

NCT05607550 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: FURMO-0042022-502977-41-00
• Study Type: interventional
• Target: 398
• Locations: 19 countries
• Sites: 208

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) determined by blinded independent central review (BICR)

  Up to 32 months after first dose

Secondary Outcomes (15)

• 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

• Duration of response (DOR)

  Up to 36 months after first dose

• Time to second Progression Free Survival (PFS2)

  Up to 36 months after first dose

Study Arms (3)

furmonertinib 240 mg

EXPERIMENTAL

Drug: furmonertinib 240 mg oral, daily

furmonertinib 160 mg

EXPERIMENTAL

Drug: furmonertinib 160 mg oral, daily

platinum-based chemotherapy

ACTIVE COMPARATOR

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

Drug: platinum-based chemotherapy

Interventions

furmonertinib 240 mg oral, daily DRUG

furmonertinib tablet

Also known as: AST2818

furmonertinib 240 mg

furmonertinib 160 mg oral, daily DRUG

furmonertinib tablet

Also known as: AST2818

furmonertinib 160 mg

platinum-based chemotherapy DRUG

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

platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• ArriVent BioPharma, Inc.: lead
• Allist Pharmaceuticals, Inc.: collaborator

Study Sites (208)

Arrivent Investigative Site

Daphne, Alabama, 36526, United States

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Arrivent Investigative Site

Yuma, Arizona, 85364, United States

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Arrivent Investigative Site

Fayetteville, Arkansas, 72703, United States

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Arrivent Investigative Site

Beverly Hills, California, 90212, United States

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Arrivent Investigative Site

Fullerton, California, 92835, United States

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Arrivent Investigative Site

Long Beach, California, 90806, United States

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Arrivent Investigative Site

Los Alamitos, California, 90720, United States

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Arrivent Investigative Site

Napa, California, 94558, United States

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Arrivent Investigative Site

Orange, California, 90868, United States

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Arrivent Investigative Site

Orange, California, 92868, United States

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Arrivent Investigative site

Sacramento, California, 95817, United States

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Arrivent Investigative Site

San Diego, California, 92123, United States

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Arrivent Investigative Site

Santa Barbara, California, 93105, United States

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Arrivent Investigative Site

Santa Monica, California, 90404, United States

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Arrivent Investigative Site

Santa Rosa, California, 95403, United States

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Arrivent Investigative Site

Whittier, California, 90602, United States

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Arrivent Investigative Site

Hartford, Connecticut, 06102, United States

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Arrivent Investigative Site

Norwich, Connecticut, 06360, United States

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Arrivent Investigative Site

Fort Myers, Florida, 33901, United States

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Arrivent Investigative Site

St. Petersburg, Florida, 33705, United States

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Arrivent Investigative Site

The Villages, Florida, 32159, United States

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Arrivent Investigative Site

Peoria, Illinois, 61615, United States

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Arrivent Investigative Site

Rolling Meadows, Illinois, 60008, United States

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Arrivent Investigative Site

Fort Wayne, Indiana, 46804, United States

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Arrivent Investigative Site

Indianapolis, Indiana, 46250, United States

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Arrivent Investigative Site

South Bend, Indiana, 46601, United States

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Arrivent Investigative Site

Bethesda, Maryland, 20817, United States

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Arrivent Investigative Site

Frederick, Maryland, 21702, United States

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Arrivent Investigative Site

Rockville, Maryland, 20850, United States

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Arrivent Investigative Site

Fairhaven, Massachusetts, 02719, United States

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Arrivent Investigative Site

Lansing, Michigan, 48912, United States

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Arrivent Investigative Site

Bolivar, Missouri, 65613, United States

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Arrivent Investigative Site

Kansas City, Missouri, 64111, United States

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Arrivent Investigative Site

Saint Joseph, Missouri, 64507, United States

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Arrivent Investigative Site

St Louis, Missouri, 63110, United States

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Arrivent Investigative Site

Omaha, Nebraska, 68114, United States

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Arrivent Investigative Site

Belleville, New Jersey, 07109, United States

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Arrivent Investigative Site

Englewood, New Jersey, 07631, United States

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Arrivent Investigative Site

Florham Park, New Jersey, 07932, United States

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Arrivent Investigative Site

The Bronx, New York, 10461, United States

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Arrivent Investigative Site

Goldsboro, North Carolina, 27534, United States

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ArriVent Investigative Site

Pinehurst, North Carolina, 28374, United States

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Arrivent Investigative Site

Canton, Ohio, 44708, United States

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Arrivent Investigative Site

Cincinnati, Ohio, 45220, United States

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ArriVent Investigative Site

Cincinnati, Ohio, 45242, United States

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Arrivent Investigative Site

Cleveland, Ohio, 44195, United States

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Arrivent Investigative Site

Columbus, Ohio, 43214, United States

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Arrivent Investigative Site

Oklahoma City, Oklahoma, 73102, United States

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Arrivent Investigative Site

Tulsa, Oklahoma, 74146, United States

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Arrivent Investigative Site

Salem, Oregon, 97301, United States

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Arrivent Investigative Site

Gettysburg, Pennsylvania, 17325, United States

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ArriVent Investigative Site

Langhorne, Pennsylvania, 19047, United States

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Arrivent Investigative Site

York, Pennsylvania, 17403, United States

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Arrivent Investigative Site

Greenville, South Carolina, 29607, United States

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Arrivent Investigative Site

Sioux Falls, South Dakota, 57117, United States

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Arrivent Investigative Site

Memphis, Tennessee, 38120, United States

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ArriVent Investigative Site

Nashville, Tennessee, 37203, United States

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Arrivent Investigative Site

Abilene, Texas, 79606, United States

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ArriVent Investigative Site

Austin, Texas, 78745, United States

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Arrivent Investigative Site

Houston, Texas, 77030, United States

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Arrivent Investigative Site

Plano, Texas, 75093, United States

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Arrivent Investigative Site

Ogden, Utah, 84405, United States

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Arrivent Investigative Site

Salt Lake City, Utah, 84106, United States

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ArriVent Investigative Site

Fairfax, Virginia, 22031, United States

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Arrivent Investigative Site

Fredericksburg, Virginia, 22408, United States

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Arrivent Investigative Site

Bellingham, Washington, 98225, United States

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Arrivent Investigative Site

Spokane Valley, Washington, 99216, United States

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Arrivent Investigative Site

Tacoma, Washington, 98405, United States

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Arrivent Investigative Site

Appleton, Wisconsin, 54911, United States

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ArriVent Investigative Site

Heidelberg, Victoria, 3084, Australia

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Arrivent Investigative Site

Blacktown, 2148, Australia

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Arrivent Investigative Site

St Leonards, NSW 2065, Australia

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Arrivent Investigative Site

Woolloongabba, 4102, Australia

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ArriVent Investigative Site

Salvador, Estado de Bahia, 40170-110, Brazil

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ArriVent Investigative Site

Belo Horizonte, Minas Gerais, 30130-090, Brazil

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ArriVent Investigative Site

Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

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ArriVent Investigative Site

Rio de Janeiro, Rio de Janeiro, 22281-100, Brazil

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ArriVent Investigative Site

Pelotas, Rio Grande do Sul, 96020-080, Brazil

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ArriVent Investigative Site

Porto Alegre, Rio Grande, 90035-903, Brazil

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ArriVent Investigative Site

Blumenau, SC Cep, 89015-200, Brazil

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ArriVent Investigative Site

São José do Rio Preto, São Paulo, 15090-000, Brazil

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ArriVent Investigative Site

São Paulo, São Paulo, 01321-001, Brazil

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ArriVent Investigative Site

Liberdade, São Paulo/SP, 01509-010, Brazil

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ArriVent Investigative Site

Taubaté, Taubate SP, 12030-200, Brazil

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ArriVent Investigative Site

Porto Alegre, 91350-200, Brazil

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ArriVent Investigative Site

Edmonton, Alberta, T6G 1Z2, Canada

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ArriVent Investigative Site

Toronto, Ontario, M5G 1Z5, Canada

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Allist Investigative Site

Beijing, Beijing Municipality, 101149, China

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Allist Investigative Site

Meizhou, Guangdong, 514000, China

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Allist Investigative Site

Xuhui, Hai City, 200030, China

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Allist Investigative Site

Hangzhou, Hangzhou, 310018, China

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Allist Investigative Site

Cangzhou, Hebei, 061011, China

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Allist Investigative Site

Shushan, Hefei, 230022, China

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Allist Investigative Site

Zhengzhou, Henan, 450052, China

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Allist Investigative Site

Changchun, Jilin, 130000, China

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Allist Investigative Site

Weihai, Lingang Economic and Technological Development Zo, 264200, China

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Allist Investigative Site

Nanning, Nanning, 530000, China

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Allist Investigative Site

Yangpu, Shanghai Municipality, 201321, China

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Allist Investigative Site

Xi’an, Shanxi, 710061, China

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Allist Investigative Site

Taiyuan, Taiyuan, 030013, China

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Allist Investigative Site

Kunming, Yunnan, 650100, China

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Allist Investigative Site

Zhejiang, Zhejiang, 310022, China

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Allist Investigative Site

Anyang, 455001, China

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Allist Investigative Site

Changchun, 130000, China

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Allist Investigative Site

Changsha, 410008, China

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Allist Investigative Site

Changsha, 410031, China

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Allist Investigative Site

Chengdu, 610041, China

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Allist Investigative Site

Chenzhou, 423099, China

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Allist Investigative Site

Chongqing, 400030, China

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Allist Investigative Site

Guangzhou, 510062, China

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Allist Investigative Site

Guangzhou, 510285, China

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Allist Investigative Site

Harbin, 150081, China

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Allist Investigative Site

Hefei, 230088, China

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Allist Investigative Site

Huai'an, 223300, China

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Allist Investigative Site

Huizhou, 516000, China

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Allist Investigative Site

Jinan, 250013, China

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Allist Investigative Site

Jinan, 250117, China

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Allist Investigative Site

Jining, 272000, China

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Allist Investigative Site

Lanzhou, 730030, China

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Allist Investigative Site

Lishui, 323020, China

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Allist Investigative Site

Luoyang, 471000, China

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Allist Investigative Site

Nanchang, 330006, China

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Allist Investigative Site

Nanchang, 330046, China

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Allist Investigative Site

Nanjing, 210009, China

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Allist Investigative Site

Ningbo, 315040, China

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Allist Investigative Site

Shanghai, 200434, China

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Allist Investigative Site

Shantou, 515031, China

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Allist Investigative Site

Shenyang, 110042, China

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Allist Investigative Site

Shenzhen, 518001, China

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Allist Investigative Site

Taiyuan, 030000, China

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Allist Investigative Site

Tianjin, 300061, China

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Allist Investigative Site

Weihui, 453000, China

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Allist Investigative Site

Wuhan, 430023, China

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Allist Investigative Site

Xiamen, 361000, China

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Allist Investigative Site

Xianyang, 441138, China

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Allist Investigative Site

Xinxiang, 453000, China

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Allist Investigative Site

Xuzhou, 221009, China

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Allist Investigative Site

Zhengzhou, 450003, China

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Arrivent Investigative Site

Caen, 14000, France

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Arrivent Investigative Site

Lyon, 69003, France

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Arrivent Investigative Site

Lyon, 69008, France

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Arrivent Investigative Site

Marseille, 13915, France

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Arrivent Investigative Site

Toulouse, 31059, France

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Arrivent Investigative Site

Villejuif, 94800, France

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ArriVent Investigative Site

Beersheba, 8410101, Israel

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ArriVent Investigative Site

Haifa, 3109601, Israel

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ArriVent Investigative Site

Jerusalem, 9103102, Israel

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ArriVent Investigative Site

Rozzano, Milan, 20089, Italy

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ArriVent Investigative Site

Aviano, PN, 33081, Italy

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ArriVent Investigative Site

Roma, Rome, 00144, Italy

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ArriVent Investigative Site

Bari, 70124, Italy

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Arrivent Investigative Site

Meldola, 47014, Italy

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ArriVent Investigative Site

Milan, 20141, Italy

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ArriVent Investigative Site

Kurume, Fukuoka, 830-0011, Japan

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Arrivent Investigative Site

Akashi, 673-8558, Japan

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Arrivent Investigative Site

Hirakata, 573-1191, Japan

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Arrivent Investigative Site

Kashiwa, 277-8577, Japan

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Arrivent Investigative Site

Nagoya, 460-0001, Japan

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Arrivent Investigative Site

Ōsaka-sayama, 589-8511, Japan

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Arrivent Investigative Site

Sapporo, 003-0804, Japan

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Arrivent Investigative Site

Sendai, 980-0873, Japan

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Arrivent Investigative Site

Shizuoka, 4118777, Japan

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Arrivent Investigative Site

Tokyo, 113-8431, Japan

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ArriVent Investigative Site

Tokyo, 113-8677, Japan

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Arrivent Investigative Site

Ube, 755-0241, Japan

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Arrivent Investigative Site

Yokohama, 241-8515, Japan

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ArriVent Investigative Site

George Town, Pulau Pinang, 10990, Malaysia

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Arrivent Investigative Site

Cheras, 56000, Malaysia

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Arrivent Investigative Site

Kota Bharu, 15586, Malaysia

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Arrivent Investigative Site

Kuala Lumpur, 50586, Malaysia

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Arrivent Investigative Site

Kuching, 93586, Malaysia

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ArriVent Investigative Site

Tuxtla Gutiérrez, Chiapas, 29038, Mexico

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ArriVent Investigative Site

Mexico City, Mexico City, 14080, Mexico

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Arrivent Investigative Site

Amsterdam, 1066 CX, Netherlands

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Arrivent Investigative Site

Harderwijk, 3844DG, Netherlands

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Arrivent Investigative Site

Cebu, 6000, Philippines

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Arrivent Investigative Site

Davao City, 8000, Philippines

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ArriVent Investigative Site

Manila, 1000, Philippines

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Arrivent Investigative Site

Pasig, 1600, Philippines

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ArriVent Investigative Site

Singapore, 119074, Singapore

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Arrivent Investigative Site

Singapore, 169610, Singapore

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ArriVent Investigative Site

Jungni I Gu, Seoul, 03181, South Korea

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Arrivent Investigative Site

Busan, 49241, South Korea

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Arrivent Investigative Site

Hwasun, 58128, South Korea

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Arrivent Investigative Site

Seoul, 2447, South Korea

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Arrivent Investigative Site

Seoul, 3722, South Korea

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Arrivent Investigative Site

Seoul, 5505, South Korea

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Arrivent Investigative Site

Seoul, 6351, South Korea

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ArriVent Investigative Site

Málaga, Malaga, 29011, Spain

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Arrivent Investigative Site

A Coruña, 15006, Spain

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Arrivent Investigative Site

Barcelona, 08035, Spain

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ArriVent Investigative Site

Madrid, 28020, Spain

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Arrivent Investigative Site

Valencia, 46026, Spain

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Arrivent Investigative Site

Chang-hua, 50006, Taiwan

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Arrivent Investigative Site

Kaohsiung City, 807, Taiwan

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ArriVent Investigative Site

Kaohsiung City, 82445, Taiwan

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ArriVent Investigative Site

Taichung, 407219, Taiwan

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Arrivent Investigative Site

Tainan, 704, Taiwan

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Arrivent Investigative Site

Taipei, 10048, Taiwan

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Arrivent Investigative Site

Bangkok, 10210, Thailand

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Arrivent Investigative Site

Bangkok, 10330, Thailand

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Arrivent Investigative Site

Bangkok, 10400, Thailand

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Arrivent Investigative Site

Hat Yai, 90110, Thailand

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ArriVent Investigative Site

Guildford, Surrey, GU2 7XX, United Kingdom

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Arrivent Investigative Site

Bebington, Wirral, CH63 4JY, United Kingdom

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ArriVent Investigative Site

London, SW3 6JJ, United Kingdom

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ArriVent Investigative Site

Manchester, M20 4BX, United Kingdom

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ArriVent Investigative Site

Sutton, SM2 5PT, United Kingdom

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib; Platinum Compounds

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Morgan Lam

  ArriVent BioPharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: June 1, 2023
• Primary Completion: August 15, 2025
• Study Completion (Estimated): February 15, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

MY (5); CA (2); IL (3); FR (6); ME (2); KR (7); TW (6); IT (6); TH (4); JP (13); AU (4); PH (4); US (69); GB (5); ES (5); CN (51); SG (2); NL (2); BR (12)