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TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
Sponsor: Takeda
Summary
The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.
Official title: A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
354
Start Date
2020-01-10
Completion Date
2026-10-31
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
TAK-788
TAK-788 capsule
Pemetrexed
Pemetrexed IV infusion
Cisplatin
Cisplatin IV infusion
Carboplatin
Carboplatin IV infusion
Locations (134)
City of Hope National Medical Center
Long Beach, California, United States
University of California Irvine
Orange, California, United States
Stanford University
Palo Alto, California, United States
AdventHealth
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center - 330 Brookline Ave
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
University of Virginia Health System
Charlottesville, Virginia, United States
GenesisCare North Shore
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Klinik Floridsdorf
Vienna, Austria
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Grand Hopital de Charleroi asbl
Charleroi, Hainaut, Belgium
AZ Sint-Lucas
Aalst, Oost-Vlaanderen, Belgium
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
William Osler Health System
Brampton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Du Sacre Coeur de Montreal
Montreal, Quebec, Canada
Beijing Cancer Hospital - PPDS
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Beijing Cancer Hospital - PPDS
Beijing, China
Beijing Chest Hospital, Capital Medical Univerity
Beijing, China
Icahn School of Medicine at Mount Sinai
Beijing, China
Sichuan Cancer Hospital & Institute
Chengdu, China
Guangdong Provincial People's Hospital
Guangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Harbin Medical University Tumor Hospital
Harbin, China
Shanghai East Hospital
Shanghai, China
Hubei Cancer Hospital
Wuhan, China
Centre Francois Baclesse
Caen, Calvados, France
CHU de Nantes - Hoptal Nord Laennec
Nantes, Loire-Atlantique, France
Hopital Calmette
Lille, Nord, France
Centre Leon Berard
Lyon, Rhone, France
Institut Gustave Roussy
Villejuif, Val-de-Marne, France
CHU de Grenoble
Grenoble, France
Hopital Nord AP-HM
Marseille, France
CRLC Val d'Aurelle - Paul Lamarque
Montpellier, France
Hopital Tenon
Paris, France
Nouvel Hopital Civil
Strasbourg, France
Hopital Larrey
Toulouse, France
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
LMU Klinikum der Universitat Munchen
München, Bavaria, Germany
University Clinic Regensburg
Regensburg, Bavaria, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, Germany
Helios Klinikum Emil Von Behring
Berlin, Germany
Sotiria Chest Hospital of Athens
Athens, Attica, Greece
Bioclinic Thessaloniki (Galinos clinic)
Thessaloniki, Greece
Princess Margaret Hospital
Kowloon City, Kowloon City, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital (QEH)
Hong Kong, Hong Kong
Queen Mary Hospital - PPDS
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Soroka University Medical Centre
Beersheba, Israel
Sheba Medical Center - PPDS
Ramat Gan, Israel
AORN Dei Colli- Ospedale Monaldi Napoli
Naples, Campania, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
Meldola, Forli-Cesena, Italy
Istituto Nazionale Dei Tumori
Milan, Lombardy, Italy
Instituto Europeo Di Oncologia
Milan, Lombardy, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, Italy
Centro Di Riferimento Oncologico
Aviano, Pordenone, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Ospedale Santa Maria Delle Croci
Ravenna, Italy
Fujita Health University Hospital
Toyoake-Shi, Aiti, Japan
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, Japan
Ehime University Hospital
Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka International Cancer Institute
Chuo Ku, Osaka, Japan
Saitama Cancer Center
Komoro, Saitama, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-Ku, Tokyo, Japan
VU Medisch Centrum
Amsterdam, North Holland, Netherlands
Centro Hospitalar do Porto Hospital de Santo Antonio
Santa Maria da Feira, Aveiro District, Portugal
Hospital Cuf Porto
Vila Nova de Gaia, Porto District, Portugal
Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente
Lisbon, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, Portugal
Centro Hospitalar de Sao Joao, E.P.E.
Porto, Portugal
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, Leningradskaya Oblast', Russia
LLC "EuroCityClinic"
Saint Petersburg, Sankt-Peterburg, Russia
National Cancer Centre
Singapore, Singapore
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Pusan National University Hospital
Busan, South Korea
National Cancer Center
Goyang, South Korea
Chonnam National University Hwasun Hospital
Jeongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center - PPDS
Seoul, South Korea
Samsung Medical Center PPDS
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, South Korea
ICO lHospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario A Coruna
A Coruña, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz - PPDS
Madrid, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Karolinska Universitetssjukhuset Solna
Stockholm, Södermanland County, Sweden
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Dalin, Taiwan
National Taiwan University Hospital - YunLin Branch
Douliu, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
E-DA hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chi Mei Medical Center, Liouying
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Baskent University Medical Faculty Adana Practice and Research Center
Yüreğir, Adana, Turkey (Türkiye)
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, Istanbul, Turkey (Türkiye)
Ege University Medical Faculty
Bornova, İzmir, Turkey (Türkiye)
SAKARYA University Medical Faculty
Karaman, Sakarya, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, Turkey (Türkiye)
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Private Enterprise Private Manufacturing Company Acinus
Kropyvnytskyi, Ukraine
University College London Hospitals (UCLH)
London, London, City of, United Kingdom
Royal Marsden Hospital - Surrey
Sutton, Surrey, United Kingdom
Clatterbridge Centre For Oncology
Bebington, Wirral, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
The Christie NHS Foundation Trust - PPDS
Manchester, United Kingdom