Lung Cancer Clinical Trial

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

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.

View Full Description

Full Description

The drug being tested in this study is called TAK-788. TAK-788 is being tested to evaluate the efficacy as a first line treatment compare with platinum-based chemotherapy in the participants with locally advanced or NSCLC whose tumors harbor EGFR exon 20 insertion mutations.

The study will enroll approximately 318 patients. Participants will be randomly assigned to one of the two treatment groups-

TAK-788 Group (Arm A)
Platinum-based Chemotherapy Group (Arm B)

The participants will be administered with TAK-788 orally in arm A and pemetrexed/cisplatin or pemetrexed/carboplatin intravenously (IV) in arm B until the participants experience progressive disease (PD) as assessed by blinded independent review committee (IRC), intolerable toxicity or another discontinuation criteria. Participants in the chemotherapy group may cross over to treatment with TAK-788 after IRC-assessed PD is documented. Randomized treatment with TAK-788 or platinum-based chemotherapy may be continued after PD, at the discretion of the investigator and with the sponsor's approval, if there is still evidence of clinical benefit.

This multi-center trial will be conducted in United States (US), Europe, and Asia. The overall time to participate in this study is until 3 years after the last participant is randomized. Participants will make multiple visits to the clinic and will be followed for survival, subsequent anticancer therapy, subsequent disease assessment outcome until disease progression on a subsequent anticancer therapy, and participant-reported health status (EuroQoL-5 Dimensions-5 Levels [EQ-5D-5L]) for 3 years after the last participant is randomized in the study and 30 days after the last dose of study drug for safety follow-up.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Received prior systemic treatment for locally advanced or metastatic disease, including local administration, such as intra-pleural injection of anticancer medication with the exception noted below:

Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or combined modality chemotherapy/radiation for locally advanced disease is allowed if completed >6 months before the development of metastatic disease.
Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities
Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before first dose of TAK-788
Have been diagnosed with another primary malignancy other than NSCLC
Have current spinal cord compression or leptomeningeal disease
Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin
Taking medication(s) known to be associated with the development of torsades de pointes.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

354

Study ID:

NCT04129502

Recruitment Status:

Active, not recruiting

Sponsor:

Takeda

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There are 122 Locations for this study

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City of Hope National Medical Center
Long Beach California, 90813, United States
University of California Irvine
Orange California, 92868, United States
Stanford University
Palo Alto California, 94304, United States
AdventHealth
Orlando Florida, 32804, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Beth Israel Deaconess Medical Center - 330 Brookline Ave
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Massachusetts General Hospital
Boston Massachusetts, 02115, United States
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
GenesisCare North Shore
St Leonards New South Wales, 2065, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Klinik Floridsdorf
Wien , 1210, Austria
Cliniques Universitaires Saint-Luc
Bruxelles Brussels, 1200, Belgium
Grand Hopital de Charleroi asbl
Charleroi Hainaut, 6000, Belgium
AZ Sint-Lucas
Aalst Oost-Vlaanderen, 9300, Belgium
British Columbia Cancer Agency
Vancouver British Columbia, V5Z-4, Canada
William Osler Health System
Brampton Ontario, L6R 3, Canada
Princess Margaret Hospital
Toronto Ontario, M5G2M, Canada
Hopital Du Sacre Coeur de Montreal
Montreal Quebec, H4J 1, Canada
Beijing Cancer Hospital - PPDS
Beijing Beijing, 10014, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Jilin Cancer Hospital
Changchun Jilin, 13001, China
Beijing Cancer Hospital - PPDS
Beijing , 10014, China
Beijing Chest Hospital, Capital Medical Univerity
Beijing , 10114, China
Icahn School of Medicine at Mount Sinai
Beijing , , China
Sichuan Cancer Hospital & Institute
Chengdu , 61004, China
Guangdong Provincial People's Hospital
Guangzhou , 51008, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou , 31000, China
Harbin Medical University Tumor Hospital
Harbin , 15008, China
Shanghai East Hospital
Shanghai , 20012, China
Hubei Cancer Hospital
Wuhan , 43007, China
Centre Francois Baclesse
Caen Calvados, 14076, France
CHU de Nantes - Hoptal Nord Laennec
Nantes Loire-Atlantique, 44000, France
Hopital Calmette
Lille Nord, 59037, France
Centre Leon Berard
Lyon Rhone, 69373, France
Institut Gustave Roussy
Villejuif Val-de-Marne, 94805, France
CHU de Grenoble
Grenoble , 38043, France
Hopital Nord AP-HM
Marseille , 13915, France
CRLC Val d'Aurelle - Paul Lamarque
Montpellier , 34298, France
Hopital Tenon
Paris , 75020, France
Nouvel Hopital Civil
Strasbourg , 67091, France
Hopital Larrey
Toulouse , 31059, France
Thoraxklinik-Heidelberg gGmbH
Heidelberg Baden-Wurttemberg, 69126, Germany
LMU Klinikum der Universitat Munchen
Munchen Bayern, 80336, Germany
University Clinic Regensburg
Regensburg Bayern, 93053, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main Hessen, 60596, Germany
Pius Hospital Oldenburg
Oldenburg Niedersachsen, 26121, Germany
Helios Klinikum Emil Von Behring
Berlin , 14165, Germany
Sotiria Chest Hospital of Athens
Athens Attiki, 11527, Greece
Bioclinic Thessaloniki (Galinos clinic)
Thessaloniki , 546 2, Greece
Princess Margaret Hospital
Kowloon 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
Sha Tin , , Hong Kong
Soroka University Medical Centre
Beer Sheva , 84101, Israel
Sheba Medical Center - PPDS
Ramat Gan , 52621, Israel
AORN Dei Colli- Ospedale Monaldi Napoli
Napoli Campania, 80131, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
Meldola Forli-Cesena, 47014, Italy
Istituto Nazionale Dei Tumori
Milano Lombardia, 20133, Italy
Instituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano Piemonte, 10043, Italy
Centro Di Riferimento Oncologico
Aviano Pordenone, 33081, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa Toscana, 56124, Italy
Azienda Ospedaliero Universitaria di Parma
Parma , 43126, Italy
Ospedale Santa Maria Delle Croci
Ravenna , 48121, Italy
Fujita Health University Hospital
Toyoake-Shi Aiti, 470-1, Japan
Ehime University Hospital
Matsuyama-Shi Ehime, 791-0, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo-Shi Hokkaido, 003-0, Japan
Kurume University Hospital
Kurume-Shi Hukuoka, 830-0, Japan
Kanagawa Cancer Center
Yokohama-Shi Kanagawa, 241-0, Japan
Saiseikai Kumamoto Hospital
Kumamoto-Shi Kumamoto, 861-4, Japan
Miyagi Cancer Center
Natori-Shi Miyagi, 981-1, Japan
Okayama University Hospital
Okayama-Shi Okayama, 700-0, Japan
Osaka International Cancer Institute
Chuo Ku Osaka, 540-0, Japan
Saitama Cancer Center
Komoro Saitama, 362-0, Japan
National Cancer Center Hospital East
Kashiwa-Shi Tiba, 277-0, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-Ku Tokyo, 135-0, Japan
Chungbuk National University Hospital
Cheongju-si Chungcheongbugdo, 28644, Korea, Republic of
Pusan National University Hospital
Busan , 602-7, Korea, Republic of
National Cancer Center
Goyang , 41076, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeongnam , 519-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center - PPDS
Seoul , 05505, Korea, Republic of
Samsung Medical Center PPDS
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS
Seoul , 120-7, Korea, Republic of
VU Medisch Centrum
Amsterdam Noord-Holland, 1081 , Netherlands
Centro Hospitalar do Porto Hospital de Santo Antonio
Santa Maria Da Feira Aveiro, 4520-, Portugal
Hospital Cuf Porto
Vila Nova de Gaia Porto, 4434-, Portugal
Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente
Lisboa , 1769-, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto , 4200-, Portugal
Centro Hospitalar de Sao Joao, E.P.E.
Porto , 4200, Portugal
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg Leningradskaya Oblast, 19775, Russian Federation
LLC "EuroCityClinic"
Saint Petersburg Sankt-Peterburg, 19702, Russian Federation
National Cancer Centre
Singapore , 16960, Singapore
ICO lHospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Universitario A Coruna
A Coruna , 15006, Spain
Hospital General Universitario de Alicante
Alicante , 03010, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
C.H. Regional Reina Sofia - PPDS
Cordoba , 14004, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz - PPDS
Madrid , 28046, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Karolinska Universitetssjukhuset Solna
Stockholm Sodermanlands Lan, , Sweden
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Dalin , 622, Taiwan
National Taiwan University Hospital - YunLin Branch
Douliu , 640, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
E-DA hospital
Kaohsiung , 82445, Taiwan
Taichung Veterans General Hospital
Taichung City , 407, Taiwan
Chi Mei Medical Center, Liouying
Tainan City , 736, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei Veterans General Hospital
Taipei , 112, Taiwan
Baskent University Medical Faculty Adana Practice and Research Center
Yuregir Adana, 01120, Turkey
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadikoy Istanbul, 34772, Turkey
Ege University Medical Faculty
Bornova Izmir, 35100, Turkey
SAKARYA University Medical Faculty
Karaman Sakarya, 54290, Turkey
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Trakya University Medical Faculty
Edirne , 22030, Turkey
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
Dnipropetrovsk Dnipropetrovs'ka Oblast, 49102, Ukraine
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv Kharkivs'ka Oblast, 61070, Ukraine
Private Enterprise Private Manufacturing Company Acinus
Kropyvnytskyi , 25006, Ukraine
University College London Hospitals (UCLH)
London London, City Of, NW1 2, United Kingdom
Royal Marsden Hospital - Surrey
Sutton Surrey, SM2 5, United Kingdom
Clatterbridge Centre For Oncology
Bebington Wirral, CH63 , United Kingdom
Leicester General Hospital
Leicester , LE1 5, United Kingdom
The Christie NHS Foundation Trust - PPDS
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

354

Study ID:

NCT04129502

Recruitment Status:

Active, not recruiting

Sponsor:


Takeda

How clear is this clinincal trial information?

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