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

Who is this study for? Patients with non-small cell lung cancer with EGFR exon 20 insertion mutations
Status: Active, not recruiting
Location: See all (177) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare the 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Male or female adult patients (aged 18 years or older)

• Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC

• Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (US sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors [TKIs] (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)

• Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation

• At least 1 measurable lesion per RECIST Version 1.1

• Life expectancy ≥3 months

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Adequate organ and hematologic function as defined by blood transfusions with a recommended >/ 14 day washout period.

Locations
United States
California
UC San Diego Moores Cancer Center
La Jolla
City of Hope National Medical Center
Long Beach
California Research Institute
Los Angeles
University of California Irvine
Orange
Stanford University
Palo Alto
Connecticut
Eastern CT Hematology and Oncology Associates
Norwich
Florida
AdventHealth
Orlando
Illinois
Northwestern University
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Dana Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Maryland
University of Maryland Greenebaum Cancer Center
Baltimore
New York
Icahn School of Medicine at Mount Sinai
New York
Pennsylvania
Fox Chase Cancer Center
Philadelphia
Tennessee
Sarah Cannon Cancer Center
Nashville
Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
Dallas
Virginia
University of Virginia Health System
Charlottesville
Other Locations
Australia
Flinders Medical Centre
Bedford Park
Royal Hobart Hospital
Hobart
St George Hospital
Kogarah
GenesisCare North Shore
St Leonards
Princess Alexandra Hospital
Woolloongabba
Austria
Medizinische Universitat Graz
Graz
Klinik Floridsdorf
Wien
Belgium
AZ Sint-Lucas
Aalst
Cliniques Universitaires Saint-Luc
Bruxelles
Grand Hopital de Charleroi asbl
Charleroi
Canada
William Osler Health System
Brampton
Hopital Du Sacre Coeur de Montreal
Montreal
Princess Margaret Hospital
Toronto
British Columbia Cancer Agency
Vancouver
China
Beijing Cancer Hospital
Beijing
Beijing Cancer Hospital
Beijing
Beijing Chest Hospital, Capital Medical Univerity
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Jilin Cancer Hospital
Changchun
Sichuan Cancer Hospital & Institute
Chengdu
Guangdong Provincial People's Hospital
Guangzhou
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou
Harbin Medical University Tumor Hospital
Harbin
The Second Affiliated Hospital of Nanchang University
Nanchang
Shanghai East Hospital
Shanghai
Hubei Cancer Hospital
Wuhan
Henan Cancer Hospital
Zhengzhou
Denmark
Copenhagen University Hospital
Copenhagen
Odense Universitetshospital
Odense C
France
Hopital Louis Pradel
Bron
Centre Francois Baclesse
Caen
Centre Hospitalier Intercommunal
Creteil Cedex
CHU de Grenoble
Grenoble
Hopital Calmette
Lille
Centre Leon Berard
Lyon
Hopital Nord AP-HM
Marseille
CRLC Val d'Aurelle - Paul Lamarque
Montpellier
CHU de Nantes - Hoptal Nord Laennec
Nantes
Hopital Tenon
Paris
Hopital PONTCHAILLOU CHU de Rennes
Rennes
Nouvel Hopital Civil
Strasbourg
Hopital Larrey
Toulouse
Institut Gustave Roussy
Villejuif
Germany
Helios Klinikum Emil Von Behring
Berlin
Malteser Krankenhaus St. Franziskus-Hospital
Flensburg
Universitatsklinikum Frankfurt
Frankfurt Am Main
Asklepios Fachkliniken GmbH
Gauting
Klinik Schillerhohe
Gerlingen
Thoraxklinik-Heidelberg gGmbH
Heidelberg
Stadtischen Krankenhaus Kiel
Kiel
LMU Klinikum der Universitat Munchen
Munchen
Pius Hospital Oldenburg
Oldenburg
University Clinic Regensburg
Regensburg
Greece
Sotiria Chest Hospital of Athens
Athens
Metaxa Cancer Hospital of Piraeus
Piraeus
Bioclinic Thessaloniki (Galinos clinic)
Thessaloniki
Hong Kong Special Administrative Region
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Queen Elizabeth Hospital (QEH)
Hong Kong
Queen Mary Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
Princess Margaret Hospital
Kowloon
Prince of Wales Hospital
Sha Tin
Israel
Soroka University Medical Centre
Beer Sheva
Rambam Medical Center PPDS
Haifa
Meir Medical Center
Kfar Saba
Sheba Medical Center - PPDS
Ramat Gan
Italy
Centro Di Riferimento Oncologico
Aviano
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS
Meldola
Istituto Europeo Di Oncologia
Milano
Istituto Nazionale Dei Tumori
Milano
AORN Dei Colli- Ospedale Monaldi Napoli
Napoli
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano
Azienda Ospedaliero Universitaria di Parma
Parma
Azienda Ospedaliero Universitaria Pisana
Pisa
Ospedale Santa Maria Delle Croci
Ravenna
Japan
Osaka International Cancer Institute
Chuo-ku
Hiroshima University Hospital
Hiroshima-shi
National Cancer Center Hospital East
Kashiwa-shi
Saitama Cancer Center
Komoro
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-ku
Saiseikai Kumamoto Hospital
Kumamoto-shi
Kurume University Hospital
Kurume-shi
Ehime University Hospital
Matsuyama-shi
Miyagi Cancer Center
Natori-shi
Okayama University Hospital
Okayama-shi
Osaka Metropolitan University Hospital
Osaka-shi
Kindai University Hospital
Osakasayama-shi
National Hospital Organization Hokkaido Cancer Center
Sapporo-shi
Fujita Health University Hospital
Toyoake-shi
National Hospital Organization Yamaguchi-Ube Medical Center
Ube-shi
Kanagawa Cancer Center
Yokohama-shi
Netherlands
VU Medisch Centrum
Amsterdam
Portugal
Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente
Lisboa
Fundacao Champalimaud
Lisboa
Centro Hospitalar de Sao Joao, E.P.E.
Porto
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto
Centro Hospitalar do Porto Hospital de Santo Antonio
Santa Maria Da Feira
Hospital Cuf Porto
Vila Nova De Gaia
Republic of Korea
Pusan National University Hospital
Busan
Chungbuk National University Hospital
Cheongju-si
National Cancer Center
Goyang
Chonnam National University Hwasun Hospital
Jeongnam
Asan Medical Center - PPDS
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center PPDS
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System - PPDS
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Russian Federation
Moscow City Oncology Hospital #62
Moscow
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg
LLC EuroCityClinic
Saint Petersburg
Scientific Research Institute of Oncology n.a. N.N. Petrov
St. Petersburg
Singapore
National Cancer Centre
Singapore
Spain
Hospital Universitario A Coruna
A Coruna
Hospital General Universitario de Alicante
Alicante
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
Barcelona
C.H. Regional Reina Sofia - PPDS
Cordoba
ICO lHospitalet Hospital Duran i Reynals
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario La Paz - PPDS
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda
Hospital Regional Universitario de Malaga Hospital General
Malaga
Hospital Universitario Virgen del Rocio - PPDS
Sevilla
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Sweden
Sahlgrenska Universitetssjukhuset
Goteborg
Karolinska Universitetssjukhuset Solna
Stockholm
Switzerland
Universitatsspital Basel
Basel
Kantonsspital Winterthur
Winterthur
Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Dalin
National Taiwan University Hospital - YunLin Branch
Douliu
E-DA hospital
Kaohsiung
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung
Taichung Veterans General Hospital
Taichung City
National Cheng Kung University Hospital
Tainan
Chi Mei Medical Center, Liouying
Tainan City
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Turkey
Hacettepe University Medical Faculty
Ankara
Ege University Medical Faculty
Bornova
Trakya University Medical Faculty
Edirne
Istanbul University Cerrahpasa Medical Faculty Hospital
Fatih
Kocaeli University Hospital
Izmit
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadikoy
SAKARYA University Medical Faculty
Karaman
Baskent University Medical Faculty Adana Practice and Research Center
Yuregir
Ukraine
Municipal Non-profit Enterprise City Clinical Hospital # 4 of Dnipro City Council - PPDS
Dnipropetrovsk
Municipal Non-profit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC
Ivano-frankivsk
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv
Private Enterprise Private Manufacturing Company Acinus
Kropyvnytskyi
United Kingdom
Clatterbridge Centre For Oncology
Bebington
Leicester General Hospital
Leicester
Royal Marsden Hospital - London
London
University College London Hospitals (UCLH)
London
The Christie NHS Foundation Trust - PPDS
Manchester
Royal Marsden Hospital - Surrey
Sutton
Velindre Cancer Centre - PPDS
Whitchurch
Time Frame
Start Date: January 10, 2020
Estimated Completion Date: June 12, 2026
Participants
Target number of participants: 354
Treatments
Experimental: TAK-788 Group (Arm A)
TAK-788 160 milligram (mg) with or without food, capsules, orally, once daily until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria.
Active Comparator: Platinum-based Chemotherapy Group (Arm B)
Pemetrexed 500 milligram per meter square (mg/m^2) plus cisplatin 75 mg/m^2, infusion, IV, once on Day 1 of 21-day cycle pemetrexed 500 mg/m^2 plus carboplatin, infusion, IV, once at a dose calculated to produce area under curve (AUC) of 5 milligram*minute per milliliter (mg*min/mL) on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/cisplatin or pemetrexed/carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m^2, on Day 1 of a 21-day cycle thereafter.
Authors
Ronald Yanagihara, Deborah Doroshow, Christian Rolfo, Viola Zhu, Daniel Costa, Dinesh Kapur, Lyudmila Bazhenova, Jyoti Patel, Luis Paz-Ares Rodriguez, Jessica Bauman, Ghassan Al-Jazayrly, Pasi Janne, Tarek Mekhail, Kathryn Mileham, Danny Nguyen, Ryan Gentzler, Min Park, Michael Thomas, Kartik Konduri, Zofia Piotrowska, Antonio Araujo, Juan Li, Elvire Pons, Radj Gervais, Niels Reinmuth, Isabelle Monnet, Alexis Benjamin Cortot, Fabrice Barlesi, Raffaele Califano, Xavier Quantin, Pascale Tomasini, Jacques Cadranel, Julien Mazieres, Benjamin Besse, Denis Moro-Sibilot, Bertrand Mennecier, Maurice Perol, Roland Repp, Martin Reck, Herve Lena, Samreen Ahmed, Amanda Tufman, Jurgen Wolf, Albera Burchardt, Michael Duruisseaux, Jens Kollmeier, Nadezda Basara, Mirjana Wollner, Bartomeu Massuti Sureda, Chao-Hsun Chen, Paul Shaw, Bengt Bergman, Spyros Ksinogalos, Melissa Johnson, Ana Maria Galeote, Marina Garassino, Kevin Jao, Philippe Collard, Siow-Ming Lee, Alev Turker, Ana Rodrigues, Chun-Liang Lai, Enriqueta Felip Font, Chiara Bennati, Maria Mastrogianni, Cristina Oliveira, Kam-Hung Wong, Ashley Cheng, Sayed Hashemi, Yu-Feng Wei, Carles Escriu, Erdem Goker, Devrim Cabuk, Jens Benn Sorensen, Elke Govaerts, Evelin Sandner, Nick Pavlakis, Lise Eckhoff, Maximilian Hochmair, Jair Bar, Myung-Ju Ahn, Zhongliang Guo, Jen-Yu Hung, Laetitia Mauti, Morihito Okada, Joel Neal, Ilhan Hacibekiroglu, Irfan Cicin, Baolan Li, Gabriela Fernandes, Saadettin Kilickap, Cemil Bilir, Yair Bar, Chee Lee, Isidoro Carlos Barneto Aranda, Toru Kumagai, Kenneth OByrne, Tanujaa Rajasekaran, Ki Hyeong Lee, Fumiyoshi Ohyanagi, Reyes Bernabe Caro, Terufumi Kato, Ioannis Boukovinas, Fedor Moiseenko, Noriko Yanagitani, Gee-Chen Chang, Koichi Azuma, Frank Griesinger, Igor Bondarenko, Hector Soto-Parra, Anwen Liu, Young-Chul Kim, James Ho, Tsung-Ying Yang, Yanping Hu, Byoung Chul Cho, Ernest Nadal, Solange Peters, Grygorii Ursol, Marcello Tiseo, Ji-Youn Han, Sanjay Popat, Eiki Ichihara, Sang-We Kim, Konstantinos Syrigos, Nuno Gil, Tony Mok, Geoffrey Liu, Tsz Yeung Michael Kam, Hiroki Izumi, Wu-Chou Su, Hiroshi Yokouchi, Gudrun Absenger, Yan Wang, Louise Nott, Alessandra Bearz, Sergey Orlov, Oscar Jose Juan Vidal, Angelo Delmonte, Jun Zhao, JinHyoung Kang, Luigi De Petris, Kodai Kawamura, Oleh Kobziev, Julia Dudnik, Jian Fang, Baogang Liu, Tae Min Kim, Antonio Calles Blanco, Gabriele Minuti, Chung-Yu Chen, Maria Rosario Garcia Campelo, Barbara Parente, Tatsuro Fukuhara, Daniil Stroyakovskiy, Christos Karapetis, Encarnacao Teixeira, Benoit Colinet, Yuh-Min Chen, Jaafar Bennouna, Maya Gottfried, Kirstin Perdrizet, Danilo Rocco, Evgeny Levchenko, Barbara Melosky, Naoyuki Nogami, Jianying Zhou, Sacha Rothschild, Christian Schulz, Aliyah Pabani, Filippo De Marinis, Iacopo Petrini, Ying Cheng, Mahmut Gumus, Binchao Wang, Mustafa Ozguroglu, Chih-Hsin Yang, Anna Kryzhanivska, Sang Won Shin, Manuel Domine Gomez, Noemi Reguart, Mariano Provencio Pulla, Ozgur Ozyilkan, Jiaxin Niu, Federico Cappuzzo, Shi Feng Nyaw, Claudia Proto, Tine McCulloch, Silvia Novello, Nir Peled, Yanqiu Zhao, Hidetoshi Hayashi, Javier De Castro Carpeno, Min Ki Lee, Yilong Wu
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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