Metastatic Non-Small Cell Lung CancerPhase 3NCT05607550

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)

A Phase 3 study testing furmonertinib 240 mg oral, daily, furmonertinib 160 mg oral, daily and platinum-based chemotherapy in people with Metastatic Non-Small Cell Lung Cancer and Advanced Non-Small Cell Lung Cancer, run by ArriVent BioPharma, Inc. at 208 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations
What is being tested?: furmonertinib 240 mg oral, daily, furmonertinib 160 mg oral, daily and platinum-based chemotherapy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 398 participants
Where: 208 sitesin 19 countries
Study dates: 1 Jun 2023to 15 Feb 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

208 sites in 19 countries.

Country

City, postcode or hospital

208 sites in 19 countries

United States69 sites

Arrivent Investigative Site
Abilene, Texas, 79606
Arrivent Investigative Site
Appleton, Wisconsin, 54911
ArriVent Investigative Site
Austin, Texas, 78745
Arrivent Investigative Site
Belleville, New Jersey, 07109
Arrivent Investigative Site
Bellingham, Washington, 98225
Arrivent Investigative Site
Bethesda, Maryland, 20817
Arrivent Investigative Site
Beverly Hills, California, 90212
Arrivent Investigative Site
Bolivar, Missouri, 65613
Arrivent Investigative Site
Canton, Ohio, 44708
Arrivent Investigative Site
Cincinnati, Ohio, 45220
ArriVent Investigative Site
Cincinnati, Ohio, 45242
Arrivent Investigative Site
Cleveland, Ohio, 44195
Arrivent Investigative Site
Columbus, Ohio, 43214
Arrivent Investigative Site
Daphne, Alabama, 36526
Arrivent Investigative Site
Englewood, New Jersey, 07631
ArriVent Investigative Site
Fairfax, Virginia, 22031
Arrivent Investigative Site
Fairhaven, Massachusetts, 02719
Arrivent Investigative Site
Fayetteville, Arkansas, 72703
Arrivent Investigative Site
Florham Park, New Jersey, 07932
Arrivent Investigative Site
Fort Myers, Florida, 33901
Arrivent Investigative Site
Fort Wayne, Indiana, 46804
Arrivent Investigative Site
Frederick, Maryland, 21702
Arrivent Investigative Site
Fredericksburg, Virginia, 22408
Arrivent Investigative Site
Fullerton, California, 92835
Arrivent Investigative Site
Gettysburg, Pennsylvania, 17325
Arrivent Investigative Site
Goldsboro, North Carolina, 27534
Arrivent Investigative Site
Greenville, South Carolina, 29607
Arrivent Investigative Site
Hartford, Connecticut, 06102
Arrivent Investigative Site
Houston, Texas, 77030
Arrivent Investigative Site
Indianapolis, Indiana, 46250
Arrivent Investigative Site
Kansas City, Missouri, 64111
ArriVent Investigative Site
Langhorne, Pennsylvania, 19047
Arrivent Investigative Site
Lansing, Michigan, 48912
Arrivent Investigative Site
Long Beach, California, 90806
Arrivent Investigative Site
Los Alamitos, California, 90720
Arrivent Investigative Site
Memphis, Tennessee, 38120
Arrivent Investigative Site
Napa, California, 94558
ArriVent Investigative Site
Nashville, Tennessee, 37203
Arrivent Investigative Site
Norwich, Connecticut, 06360
Arrivent Investigative Site
Ogden, Utah, 84405
Arrivent Investigative Site
Oklahoma City, Oklahoma, 73102
Arrivent Investigative Site
Omaha, Nebraska, 68114
Arrivent Investigative Site
Orange, California, 90868
Arrivent Investigative Site
Orange, California, 92868
Arrivent Investigative Site
Peoria, Illinois, 61615
ArriVent Investigative Site
Pinehurst, North Carolina, 28374
Arrivent Investigative Site
Plano, Texas, 75093
Arrivent Investigative Site
Rockville, Maryland, 20850
Arrivent Investigative Site
Rolling Meadows, Illinois, 60008
Arrivent Investigative site
Sacramento, California, 95817
Arrivent Investigative Site
Saint Joseph, Missouri, 64507
Arrivent Investigative Site
Salem, Oregon, 97301
Arrivent Investigative Site
Salt Lake City, Utah, 84106
Arrivent Investigative Site
San Diego, California, 92123
Arrivent Investigative Site
Santa Barbara, California, 93105
Arrivent Investigative Site
Santa Monica, California, 90404
Arrivent Investigative Site
Santa Rosa, California, 95403
Arrivent Investigative Site
Sioux Falls, South Dakota, 57117
Arrivent Investigative Site
South Bend, Indiana, 46601
Arrivent Investigative Site
Spokane Valley, Washington, 99216
Arrivent Investigative Site
St Louis, Missouri, 63110
Arrivent Investigative Site
St. Petersburg, Florida, 33705
Arrivent Investigative Site
Tacoma, Washington, 98405
Arrivent Investigative Site
The Bronx, New York, 10461
Arrivent Investigative Site
The Villages, Florida, 32159
Arrivent Investigative Site
Tulsa, Oklahoma, 74146
Arrivent Investigative Site
Whittier, California, 90602
Arrivent Investigative Site
York, Pennsylvania, 17403
Arrivent Investigative Site
Yuma, Arizona, 85364

Other trials in United States

China51 sites

Allist Investigative Site
Anyang, 455001
Allist Investigative Site
Beijing, Beijing Municipality, 101149
Allist Investigative Site
Cangzhou, Hebei, 061011
Allist Investigative Site
Changchun, Jilin, 130000
Allist Investigative Site
Changchun, 130000
Allist Investigative Site
Changsha, 410008
Allist Investigative Site
Changsha, 410031
Allist Investigative Site
Chengdu, 610041
Allist Investigative Site
Chenzhou, 423099
Allist Investigative Site
Chongqing, 400030
Allist Investigative Site
Guangzhou, 510062
Allist Investigative Site
Guangzhou, 510285
Allist Investigative Site
Hangzhou, Hangzhou, 310018
Allist Investigative Site
Harbin, 150081
Allist Investigative Site
Hefei, 230088
Allist Investigative Site
Huai'an, 223300
Allist Investigative Site
Huizhou, 516000
Allist Investigative Site
Jinan, 250013
Allist Investigative Site
Jinan, 250117
Allist Investigative Site
Jining, 272000
Allist Investigative Site
Kunming, Yunnan, 650100
Allist Investigative Site
Lanzhou, 730030
Allist Investigative Site
Lishui, 323020
Allist Investigative Site
Luoyang, 471000
Allist Investigative Site
Meizhou, Guangdong, 514000
Allist Investigative Site
Nanchang, 330006
Allist Investigative Site
Nanchang, 330046
Allist Investigative Site
Nanjing, 210009
Allist Investigative Site
Nanning, Nanning, 530000
Allist Investigative Site
Ningbo, 315040
Allist Investigative Site
Shanghai, 200434
Allist Investigative Site
Shantou, 515031
Allist Investigative Site
Shenyang, 110042
Allist Investigative Site
Shenzhen, 518001
Allist Investigative Site
Shushan, Hefei, 230022
Allist Investigative Site
Taiyuan, Taiyuan, 030013
Allist Investigative Site
Taiyuan, 030000
Allist Investigative Site
Tianjin, 300061
Allist Investigative Site
Weihai, Lingang Economic and Technological Development Zo, 264200
Allist Investigative Site
Weihui, 453000
Allist Investigative Site
Wuhan, 430023
Allist Investigative Site
Xi’an, Shanxi, 710061
Allist Investigative Site
Xiamen, 361000
Allist Investigative Site
Xianyang, 441138
Allist Investigative Site
Xinxiang, 453000
Allist Investigative Site
Xuhui, Hai City, 200030
Allist Investigative Site
Xuzhou, 221009
Allist Investigative Site
Yangpu, Shanghai Municipality, 201321
Allist Investigative Site
Zhejiang, Zhejiang, 310022
Allist Investigative Site
Zhengzhou, Henan, 450052
Allist Investigative Site
Zhengzhou, 450003

Other trials in China

Japan13 sites

Arrivent Investigative Site
Akashi, 673-8558
Arrivent Investigative Site
Hirakata, 573-1191
Arrivent Investigative Site
Kashiwa, 277-8577
ArriVent Investigative Site
Kurume, Fukuoka, 830-0011
Arrivent Investigative Site
Nagoya, 460-0001
Arrivent Investigative Site
Ōsaka-sayama, 589-8511
Arrivent Investigative Site
Sapporo, 003-0804
Arrivent Investigative Site
Sendai, 980-0873
Arrivent Investigative Site
Shizuoka, 4118777
ArriVent Investigative Site
Tokyo, Tokyo, 113-8677
Arrivent Investigative Site
Tokyo, 113-8431
Arrivent Investigative Site
Ube, 755-0241
Arrivent Investigative Site
Yokohama, 241-8515

Other trials in Japan

Brazil12 sites

ArriVent Investigative Site
Belo Horizonte, Minas Gerais, 30130-090
ArriVent Investigative Site
Blumenau, SC Cep, 89015-200
ArriVent Investigative Site
Liberdade, São Paulo/SP, 01509-010
ArriVent Investigative Site
Pelotas, Rio Grande do Sul, 96020-080
ArriVent Investigative Site
Porto Alegre, Porto Alegre, 91350-200
ArriVent Investigative Site
Porto Alegre, Rio Grande, 90035-903
ArriVent Investigative Site
Rio de Janeiro, Rio de Janeiro, 20231-050
ArriVent Investigative Site
Rio de Janeiro, Rio de Janeiro, 22281-100
ArriVent Investigative Site
Salvador, Estado de Bahia, 40170-110
ArriVent Investigative Site
São José do Rio Preto, São Paulo, 15090-000
ArriVent Investigative Site
São Paulo, São Paulo, 01321-001
ArriVent Investigative Site
Taubaté, Taubate SP, 12030-200

Other trials in Brazil

South Korea7 sites

Arrivent Investigative Site
Busan, 49241
Arrivent Investigative Site
Hwasun, 58128
ArriVent Investigative Site
Jungni I Gu, Seoul, 03181
Arrivent Investigative Site
Seoul, 2447
Arrivent Investigative Site
Seoul, 3722
Arrivent Investigative Site
Seoul, 5505
Arrivent Investigative Site
Seoul, 6351

Other trials in South Korea

France6 sites

Arrivent Investigative Site
Caen, 14000
Arrivent Investigative Site
Lyon, 69003
Arrivent Investigative Site
Lyon, 69008
Arrivent Investigative Site
Marseille, 13915
Arrivent Investigative Site
Toulouse, 31059
Arrivent Investigative Site
Villejuif, 94800

Other trials in France

Italy6 sites

ArriVent Investigative Site
Aviano, PN, 33081
ArriVent Investigative Site
Bari, Bari, 70124
Arrivent Investigative Site
Meldola, 47014
ArriVent Investigative Site
Milan, Milano, 20141
ArriVent Investigative Site
Roma, Rome, 00144
ArriVent Investigative Site
Rozzano, Milan, 20089

Other trials in Italy

Taiwan6 sites

Arrivent Investigative Site
Chang-hua, 50006
ArriVent Investigative Site
Kaohsiung City, Kaohsiung, 82445
Arrivent Investigative Site
Kaohsiung City, 807
ArriVent Investigative Site
Taichung, Taichung, 407219
Arrivent Investigative Site
Tainan, 704
Arrivent Investigative Site
Taipei, 10048

Other trials in Taiwan

Malaysia5 sites

Arrivent Investigative Site
Cheras, 56000
ArriVent Investigative Site
George Town, Pulau Pinang, 10990
Arrivent Investigative Site
Kota Bharu, 15586
Arrivent Investigative Site
Kuala Lumpur, 50586
Arrivent Investigative Site
Kuching, 93586

Other trials in Malaysia

Spain5 sites

Arrivent Investigative Site
A Coruña, 15006
Arrivent Investigative Site
Barcelona, 08035
ArriVent Investigative Site
Madrid, Madrid, 28020
ArriVent Investigative Site
Málaga, Malaga, 29011
Arrivent Investigative Site
Valencia, 46026

Other trials in Spain

United Kingdom5 sites

Arrivent Investigative Site
Bebington, Wirral, CH63 4JY
ArriVent Investigative Site
Guildford, Surrey, GU2 7XX
ArriVent Investigative Site
London, London, SW3 6JJ
ArriVent Investigative Site
Manchester, Manchester, M20 4BX
ArriVent Investigative Site
Sutton, Sutton, SM2 5PT

Other trials in United Kingdom

Australia4 sites

Arrivent Investigative Site
Blacktown, 2148
ArriVent Investigative Site
Heidelberg, Victoria, 3084
Arrivent Investigative Site
St Leonards, NSW 2065
Arrivent Investigative Site
Woolloongabba, 4102

Other trials in Australia

Philippines4 sites

Arrivent Investigative Site
Cebu, 6000
Arrivent Investigative Site
Davao City, 8000
ArriVent Investigative Site
Manila, Manila, 1000
Arrivent Investigative Site
Pasig, 1600

Other trials in Philippines

Thailand4 sites

Arrivent Investigative Site
Bangkok, 10210
Arrivent Investigative Site
Bangkok, 10330
Arrivent Investigative Site
Bangkok, 10400
Arrivent Investigative Site
Hat Yai, 90110

Other trials in Thailand

Israel3 sites

ArriVent Investigative Site
Beersheba, Israel, 8410101
ArriVent Investigative Site
Haifa, Israel, 3109601
ArriVent Investigative Site
Jerusalem, 9103102

Other trials in Israel

Canada2 sites

ArriVent Investigative Site
Edmonton, Alberta, T6G 1Z2
ArriVent Investigative Site
Toronto, Ontario, M5G 1Z5

Other trials in Canada

Mexico2 sites

ArriVent Investigative Site
Mexico City, Mexico City, 14080
ArriVent Investigative Site
Tuxtla Gutiérrez, Chiapas, 29038

Other trials in Mexico

Netherlands2 sites

Arrivent Investigative Site
Amsterdam, 1066 CX
Arrivent Investigative Site
Harderwijk, 3844DG

Other trials in Netherlands

Singapore2 sites

ArriVent Investigative Site
Singapore, Singapore, 119074
Arrivent Investigative Site
Singapore, 169610

Other trials in Singapore

About this study

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)

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
Being tested: furmonertinib 240 mg oral, daily, furmonertinib 160 mg oral, daily, platinum-based chemotherapy
Keywords: Non-Small Cell Lung Cancer (NSCLC), Exon 20, Furmonertinib, Firmonertinib, AST2818, FURMO-004, Drug-Therapy
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

furmonertinib 240 mg oral, dailyDrug
Also called AST2818
furmonertinib tablet
furmonertinib 160 mg oral, dailyDrug
Also called AST2818
furmonertinib tablet
platinum-based chemotherapyDrug
(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Study groups in NCT05607550
Study group	Role	What they receive
furmonertinib 240 mg	Experimental	Not described Receives: Drug: furmonertinib 240 mg oral, daily
furmonertinib 160 mg	Experimental	Not described Receives: Drug: furmonertinib 160 mg oral, daily
platinum-based chemotherapy	Active comparator	carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously Receives: Drug: platinum-based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (15)

Overall Survival (OS)
Measured: Up to 62 months after first dose
PFS determined by investigator assessment
Measured: Up to 36 months after first dose
Overall response rate (ORR)
Measured: Up to 36 months after first dose
Duration of response (DOR)
Measured: Up to 36 months after first dose
Time to second Progression Free Survival (PFS2)
Measured: Up to 36 months after first dose
PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline
Measured: Up to 36 months after first dose
Time to central nervous system (CNS) metastases by BICR
Measured: Randomization up to ≤30 days after last dose
CNS ORR evaluated by BICR
Measured: Randomization up to ≤30 days after last dose
CNS DOR evaluated by BICR
Measured: Randomization up to ≤30 days after last dose
CNS PFS evaluated by BICR
Measured: Randomization up to ≤30 days after last dose
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
QLQ-C30 is a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Measured: Randomization up to ≤30 days after last dose
Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)
QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication.
Measured: Randomization up to ≤30 days after last dose
Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)
NSCLC-SAQ consists of 7 items assessing 5 NSCLC symptom concepts: cough, pain, dyspnea, fatigue, and poor appetite.
Measured: Randomization up to ≤30 days after last dose
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Measured: Up to 36 months after first dose
Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Measured: Up to 36 months after first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202315 Feb 2028

First posted7 Nov 2022
Study start1 Jun 2023
Primary completion6 Oct 2026
Study completion15 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05607550
Sponsor's protocol ID: FURMO-004
Other IDs: 2022-502977-41-00
Status last verified: Oct 2026
First submitted: 31 Oct 2022
Last updated: 2 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05607550
Acronym / sponsor ID: FURMO-004
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 398 participants (actual)
Lead sponsor: ArriVent BioPharma, Inc.Industry (pharma, biotech, devices)
Collaborators: Allist Pharmaceuticals, Inc.
Study start: 1 Jun 2023 (actual)
Primary completion: 6 Oct 2026 (actual)
Study completion: 15 Feb 2028 (estimated)
First posted: 7 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
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	Drug: platinum-based chemotherapycarboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
furmonertinib 240 mg oral, dailyAlso: AST2818furmonertinib tablet	Drug	furmonertinib 240 mg
furmonertinib 160 mg oral, dailyAlso: AST2818furmonertinib tablet	Drug	furmonertinib 160 mg
platinum-based chemotherapy(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)	Drug	platinum-based chemotherapy

Primary outcome

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

15 secondary outcomes

Overall Survival (OS)
Time frame: Up to 62 months after first dose
PFS determined by investigator assessment
Time frame: Up to 36 months after first dose
Overall response rate (ORR)
Time frame: Up to 36 months after first dose
Duration of response (DOR)
Time frame: Up to 36 months after first dose
Time to second Progression Free Survival (PFS2)
Time frame: Up to 36 months after first dose
PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline
Time frame: Up to 36 months after first dose
Time to central nervous system (CNS) metastases by BICR
Time frame: Randomization up to ≤30 days after last dose
CNS ORR evaluated by BICR
Time frame: Randomization up to ≤30 days after last dose
CNS DOR evaluated by BICR
Time frame: Randomization up to ≤30 days after last dose
CNS PFS evaluated by BICR
Time frame: Randomization up to ≤30 days after last dose
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
Time frame: Randomization up to ≤30 days after last dose
Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)
Time frame: Randomization up to ≤30 days after last dose
Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)
Time frame: Randomization up to ≤30 days after last dose
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Time frame: Up to 36 months after first dose
Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time frame: Up to 36 months after first dose

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jamuna Thimmarayappa study director

ArriVent BioPharm

208 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in United States, China, Japan, Brazil, South Korea and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) determined by blinded independent central review (BICR) (time frame: Up to 32 months after first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05607550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.