TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
NCT ID: NCT04129502
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
354 participants
INTERVENTIONAL
2020-01-10
2026-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
TAK-788
TAK-788 capsule
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.
Pemetrexed
Pemetrexed IV infusion
Cisplatin
Cisplatin IV infusion
Carboplatin
Carboplatin IV infusion
Interventions
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TAK-788
TAK-788 capsule
Pemetrexed
Pemetrexed IV infusion
Cisplatin
Cisplatin IV infusion
Carboplatin
Carboplatin IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Napoli, 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 City, , Taiwan
Chi Mei Medical Center, Liouying
Tainan City, , 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
Countries
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References
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Janne PA, Wang BC, Cho BC, Zhao J, Li J, Hochmair M, Peters S, Besse B, Pavlakis N, Neal JW, Kato T, Wu YL, Nguyen D, Lin J, Lin J, Vranceanu F, Szumski A, Lin HM, Fram RJ, Mok TSK. First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial. J Clin Oncol. 2025 May;43(13):1553-1563. doi: 10.1200/JCO-24-01269. Epub 2025 Jan 29.
Other Identifiers
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NL20191212
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-001845-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1232-6059
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
jRCT2071210098
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-788-3001
Identifier Type: -
Identifier Source: org_study_id
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