Advanced Non-Small Cell Lung Cancer Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 375 |
| Est. completion date | February 15, 2028 |
| Est. primary completion date | August 15, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Arrivent Investigative Site | Blacktown | |
| Australia | ArriVent Investigative Site | Heidelberg | Victoria |
| Australia | Arrivent Investigative Site | St Leonards | |
| Australia | Arrivent Investigative Site | Woolloongabba | |
| Brazil | ArriVent Investigative Site | Belo Horizonte | Minas Gerais |
| Brazil | ArriVent Investigative Site | Blumenau | SC Cep |
| Brazil | ArriVent Investigative Site | Liberdade | São Paulo/SP |
| Brazil | ArriVent Investigative Site | Pelotas | RS |
| Brazil | ArriVent Investigative Site | Porto Alegre | Rio Grande |
| Brazil | ArriVent Investigative Site | Porto Alegre | |
| Brazil | ArriVent Investigative Site | Rio De Janeiro | RJ |
| Brazil | ArriVent Investigative Site | Rio De Janeiro | RJ |
| Brazil | ArriVent Investigative Site | Salvador | Bahia |
| Brazil | ArriVent Investigative Site | São José Do Rio Preto | Sao Paulo |
| Brazil | ArriVent Investigative Site | São Paulo | Sao Paulo |
| Brazil | ArriVent Investigative Site | Taubaté | Taubate SP |
| China | Allist Investigative Site | Anyang | |
| China | ArriVent Investigative Site | Beijing | Beijing |
| China | Allist Investigative Site | Changchun | Jilin |
| China | Allist Investigative Site | Changchun | |
| China | Allist Investigative Site | Changsha | |
| China | Allist Investigative Site | Changsha | |
| China | Allist Investigative Site | Chengdu | |
| China | Allist Investigative Site | Chenzhou | |
| China | Allist Investigative Site | Chongqing | |
| China | Allist Investigative Site | Guangzhou | |
| China | Allist Investigative Site | Guangzhou | |
| China | Allist Investigative Site | Harbin | |
| China | Allist Investigative Site | Hefei | |
| China | Allist Investigative Site | Huai'an | |
| China | Allist Investigative Site | Huizhou | |
| China | Allist Investigative Site | Jinan | |
| China | Allist Investigative Site | Jinan | |
| China | Allist Investigative Site | Jining | |
| China | Allist Investigative Site | Lanzhou | |
| China | Allist Investigative Site | Lishui | |
| China | Allist Investigative Site | Luoyang | |
| China | Allist Investigative Site | Meijiang | Meizhou City, Guangdong Province |
| China | Allist Investigative Site | Nanchang | |
| China | Allist Investigative Site | Nanchang | |
| China | Allist Investigative Site | Nanjing | |
| China | Allist Investigative Site | Ningbo | |
| China | Allist Investigative Site | Shanghai | |
| China | Allist Investigative Site | Shanghai | |
| China | Allist Investigative Site | Shantou | |
| China | Allist Investigative Site | Shenyang | |
| China | Allist Investigative Site | Shenzhen | |
| China | Allist Investigative Site | Shushan | Hefei |
| China | Allist Investigative Site | Taiyuan | |
| China | Allist Investigative Site | Taoyuan | |
| China | Allist Investigative Site | Tianjin | |
| China | Allist Investigative Site | Weihai | Lingang Economic And Technological Development Zo |
| China | Allist Investigative Site | Weihui | |
| China | Allist Investigative Site | Wuhan | |
| China | Allist Investigative Site | Xiamen | |
| China | Allist Investigative Site | Xianyang | |
| China | Allist Investigative Site | Xinxiang | |
| China | Allist Investigative Site | Xuhui | Hai City |
| China | Allist Investigative Site | Xuzhou | |
| China | Allist Investigative Site | Zhengzhou | |
| China | Allist Investigative Site | Zhengzhou | Henan |
| France | Arrivent Investigative Site | Caen | |
| France | Arrivent Investigative Site | Lyon | |
| France | Arrivent Investigative Site | Lyon | |
| France | Arrivent Investigative Site | Marseille | |
| France | Arrivent Investigative Site | Toulouse | |
| France | Arrivent Investigative Site | Villejuif | |
| Israel | ArriVent Investigative Site | Be'er Sheva | |
| Israel | ArriVent Investigative Site | Haifa | |
| Israel | ArriVent Investigative Site | Jerusalem | |
| Italy | ArriVent Investigative Site | Bari | |
| Italy | Arrivent Investigative Site | Meldola | |
| Italy | ArriVent Investigative Site | Milano | |
| Italy | ArriVent Investigative Site | Roma | Rome |
| Italy | ArriVent Investigative Site | Rozzano | Milan |
| Japan | Arrivent Investigative Site | Akashi | |
| Japan | Arrivent Investigative Site | Hirakata | |
| Japan | Arrivent Investigative Site | Kashiwa | |
| Japan | ArriVent Investigative Site | Kurume | Fukuoka |
| Japan | Arrivent Investigative Site | Nagoya | |
| Japan | Arrivent Investigative Site | Osaka-sayama | |
| Japan | Arrivent Investigative Site | Sapporo-shi | |
| Japan | Arrivent Investigative Site | Sendai | |
| Japan | Arrivent Investigative Site | Shizuoka | |
| Japan | Arrivent Investigative Site | Tokyo | |
| Japan | Arrivent Investigative Site | Ube | |
| Japan | Arrivent Investigative Site | Yokohama | |
| Korea, Republic of | Arrivent Investigative Site | Busan | |
| Korea, Republic of | Arrivent Investigative Site | Hwasun | |
| Korea, Republic of | ArriVent Investigative Site | Jungni I Gu | Seoul |
| Korea, Republic of | Arrivent Investigative Site | Seoul | |
| Korea, Republic of | Arrivent Investigative Site | Seoul | |
| Korea, Republic of | Arrivent Investigative Site | Seoul | |
| Korea, Republic of | Arrivent Investigative Site | Seoul | |
| Malaysia | Arrivent Investigative Site | Cheras | |
| Malaysia | ArriVent Investigative Site | George Town | Pulau Pinang |
| Malaysia | Arrivent Investigative Site | Kota Bharu | |
| Malaysia | Arrivent Investigative Site | Kuala Lumpur | |
| Malaysia | Arrivent Investigative Site | Kuching | |
| Netherlands | Arrivent Investigative Site | Amsterdam | |
| Netherlands | Arrivent Investigative Site | Harderwijk | |
| Philippines | Arrivent Investigative Site | Cebu | |
| Philippines | Arrivent Investigative Site | Davao City | |
| Philippines | ArriVent Investigative Site | Manila | |
| Philippines | Arrivent Investigative Site | Pasig | |
| Singapore | ArriVent Investigative Site | Singapore | |
| Singapore | Arrivent Investigative Site | Singapore | |
| Spain | Arrivent Investigative Site | A Coruña | |
| Spain | Arrivent Investigative Site | Barcelona | |
| Spain | ArriVent Investigative Site | Madrid | |
| Spain | ArriVent Investigative Site | Málaga | Malaga |
| Spain | Arrivent Investigative Site | Valencia | |
| Taiwan | Arrivent Investigative Site | Chang Hua | |
| Taiwan | Arrivent Investigative Site | Kaohsiung | |
| Taiwan | ArriVent Investigative Site | Kaohsiung | |
| Taiwan | ArriVent Investigative Site | Taichung | |
| Taiwan | Arrivent Investigative Site | Tainan | |
| Taiwan | Arrivent Investigative Site | Taipei | |
| Thailand | Arrivent Investigative Site | Bangkok | |
| Thailand | Arrivent Investigative Site | Bangkok | |
| Thailand | Arrivent Investigative Site | Bangkok | |
| Thailand | Arrivent Investigative Site | Hat Yai | |
| United Kingdom | ArriVent Investigative Site | Guildford | Surrey |
| United Kingdom | ArriVent Investigative Site | Manchester | |
| United States | Arrivent Investigative Site | Abilene | Texas |
| United States | Arrivent Investigative Site | Appleton | Wisconsin |
| United States | ArriVent Investigative Site | Austin | Texas |
| United States | Arrivent Investigative Site | Belleville | New Jersey |
| United States | Arrivent Investigative Site | Bellingham | Washington |
| United States | Arrivent Investigative Site | Bethesda | Maryland |
| United States | Arrivent Investigative Site | Beverly Hills | California |
| United States | Arrivent Investigative Site | Bolivar | Missouri |
| United States | Arrivent Investigative Site | Bronx | New York |
| United States | Arrivent Investigative Site | Canton | Ohio |
| United States | Arrivent Investigative Site | Cincinnati | Ohio |
| United States | ArriVent Investigative Site | Cincinnati | Ohio |
| United States | Arrivent Investigative Site | Cleveland | Ohio |
| United States | Arrivent Investigative Site | Columbus | Ohio |
| United States | Arrivent Investigative Site | Daphne | Alabama |
| United States | Arrivent Investigative Site | Englewood | New Jersey |
| United States | ArriVent Investigative Site | Fairfax | Virginia |
| United States | Arrivent Investigative Site | Fairhaven | Massachusetts |
| United States | Arrivent Investigative Site | Fayetteville | Arkansas |
| United States | Arrivent Investigative Site | Florham Park | New Jersey |
| United States | Arrivent Investigative Site | Fort Myers | Florida |
| United States | Arrivent Investigative Site | Fort Wayne | Indiana |
| United States | Arrivent Investigative Site | Frederick | Maryland |
| United States | Arrivent Investigative Site | Fredericksburg | Virginia |
| United States | Arrivent Investigative Site | Fullerton | California |
| United States | Arrivent Investigative Site | Gettysburg | Pennsylvania |
| United States | Arrivent Investigative Site | Goldsboro | North Carolina |
| United States | Arrivent Investigative Site | Greenville | South Carolina |
| United States | Arrivent Investigative Site | Hartford | Connecticut |
| United States | Arrivent Investigative Site | Houston | Texas |
| United States | Arrivent Investigative Site | Indianapolis | Indiana |
| United States | Arrivent Investigative Site | Kansas City | Missouri |
| United States | Arrivent Investigative Site | Lansing | Michigan |
| United States | Arrivent Investigative Site | Long Beach | California |
| United States | Arrivent Investigative Site | Los Alamitos | California |
| United States | Arrivent Investigative Site | Memphis | Tennessee |
| United States | Arrivent Investigative Site | Napa | California |
| United States | ArriVent Investigative Site | Nashville | Tennessee |
| United States | Arrivent Investigative Site | Norwich | Connecticut |
| United States | Arrivent Investigative Site | Ogden | Utah |
| United States | Arrivent Investigative Site | Oklahoma City | Oklahoma |
| United States | Arrivent Investigative Site | Omaha | Nebraska |
| United States | Arrivent Investigative Site | Orange | California |
| United States | Arrivent Investigative Site | Orange | California |
| United States | Arrivent Investigative Site | Peoria | Illinois |
| United States | ArriVent Investigative Site | Pinehurst | North Carolina |
| United States | Arrivent Investigative Site | Plano | Texas |
| United States | Arrivent Investigative Site | Rockville | Maryland |
| United States | Arrivent Investigative Site | Rolling Meadows | Illinois |
| United States | Arrivent Investigative site | Sacramento | California |
| United States | Arrivent Investigative Site | Saint Joseph | Missouri |
| United States | Arrivent Investigative Site | Saint Louis | Missouri |
| United States | Arrivent Investigative Site | Saint Petersburg | Florida |
| United States | Arrivent Investigative Site | Salem | Oregon |
| United States | Arrivent Investigative Site | Salt Lake City | Utah |
| United States | Arrivent Investigative Site | San Diego | California |
| United States | Arrivent Investigative Site | Santa Barbara | California |
| United States | Arrivent Investigative Site | Santa Monica | California |
| United States | Arrivent Investigative Site | Santa Rosa | California |
| United States | Arrivent Investigative Site | Sioux Falls | South Dakota |
| United States | Arrivent Investigative Site | South Bend | Indiana |
| United States | Arrivent Investigative Site | Spokane Valley | Washington |
| United States | Arrivent Investigative Site | Tacoma | Washington |
| United States | Arrivent Investigative Site | The Villages | Florida |
| United States | Arrivent Investigative Site | Tulsa | Oklahoma |
| United States | Arrivent Investigative Site | Whittier | California |
| United States | Arrivent Investigative Site | York | Pennsylvania |
| United States | Arrivent Investigative Site | Yuma | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| ArriVent BioPharma, Inc. | Allist Pharmaceuticals, Inc. |
United States, Australia, Brazil, China, France, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Philippines, Singapore, Spain, Taiwan, Thailand, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) determined by blinded independent central review (BICR) | Up to 32 months after first dose | ||
| Secondary | Overall Survival (OS) | Up to 62 months after first dose | ||
| Secondary | PFS determined by investigator assessment | Up to 36 months after first dose | ||
| Secondary | Overall response rate (ORR) | Up to 36 months after first dose | ||
| Secondary | Duration of response (DOR) | Up to 36 months after first dose | ||
| Secondary | Time to second Progression Free Survival (PFS2) | Up to 36 months after first dose | ||
| Secondary | PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline | Up to 36 months after first dose | ||
| Secondary | Time to central nervous system (CNS) metastases by BICR | Randomization up to =30 days after last dose | ||
| Secondary | CNS ORR evaluated by BICR | Randomization up to =30 days after last dose | ||
| Secondary | CNS DOR evaluated by BICR | Randomization up to =30 days after last dose | ||
| Secondary | CNS PFS evaluated by BICR | Randomization up to =30 days after last dose | ||
| Secondary | 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). | Randomization up to =30 days after last dose | |
| Secondary | 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. | Randomization up to =30 days after last dose | |
| Secondary | 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. | Randomization up to =30 days after last dose | |
| Secondary | Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib | Up to 36 months after first dose | ||
| Secondary | Plasma concentrations of furmonertinib and its major metabolite (AST5902) | Up to 36 months after first dose |
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