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ACTIVE NOT RECRUITING
NCT04129502
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

TAK-788

TAK-788 capsule

DRUG

Pemetrexed

Pemetrexed IV infusion

DRUG

Cisplatin

Cisplatin IV infusion

DRUG

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