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

Trial Title: 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

Condition: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Mobocertinib

Conditions: Keywords:
Drug Therapy

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TAK-788
Description: TAK-788 capsule
Arm group label: TAK-788 Group (Arm A)

Other name: AP32788

Other name: Mobocertinib

Intervention type: Drug
Intervention name: Pemetrexed
Description: Pemetrexed IV infusion
Arm group label: Platinum-based Chemotherapy Group (Arm B)

Other name: Alimta

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin IV infusion
Arm group label: Platinum-based Chemotherapy Group (Arm B)

Intervention type: Drug
Intervention name: Carboplatin
Description: Carboplatin IV infusion
Arm group label: Platinum-based Chemotherapy Group (Arm B)

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.

Detailed 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: City of Hope National Medical Center

Address:
City: Long Beach
Zip: 90813
Country: United States

Facility:
Name: University of California Irvine

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Stanford University

Address:
City: Palo Alto
Zip: 94304
Country: United States

Facility:
Name: AdventHealth

Address:
City: Orlando
Zip: 32804
Country: United States

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Facility:
Name: University of Maryland Greenebaum Cancer Center

Address:
City: Baltimore
Zip: 21201
Country: United States

Facility:
Name: Beth Israel Deaconess Medical Center - 330 Brookline Ave

Address:
City: Boston
Zip: 02115
Country: United States

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02115
Country: United States

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02115
Country: United States

Facility:
Name: Sarah Cannon Cancer Center

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: University of Virginia Health System

Address:
City: Charlottesville
Zip: 22908
Country: United States

Facility:
Name: GenesisCare North Shore

Address:
City: St Leonards
Zip: 2065
Country: Australia

Facility:
Name: Princess Alexandra Hospital

Address:
City: Woolloongabba
Zip: 4102
Country: Australia

Facility:
Name: Flinders Medical Centre

Address:
City: Bedford Park
Zip: 5042
Country: Australia

Facility:
Name: Klinik Floridsdorf

Address:
City: Wien
Zip: 1210
Country: Austria

Facility:
Name: Cliniques Universitaires Saint-Luc

Address:
City: Bruxelles
Zip: 1200
Country: Belgium

Facility:
Name: Grand Hopital de Charleroi asbl

Address:
City: Charleroi
Zip: 6000
Country: Belgium

Facility:
Name: AZ Sint-Lucas

Address:
City: Aalst
Zip: 9300
Country: Belgium

Facility:
Name: British Columbia Cancer Agency

Address:
City: Vancouver
Zip: V5Z-4E6
Country: Canada

Facility:
Name: William Osler Health System

Address:
City: Brampton
Zip: L6R 3J7
Country: Canada

Facility:
Name: Princess Margaret Hospital

Address:
City: Toronto
Zip: M5G2M9
Country: Canada

Facility:
Name: Hopital Du Sacre Coeur de Montreal

Address:
City: Montreal
Zip: H4J 1C5
Country: Canada

Facility:
Name: Beijing Cancer Hospital - PPDS

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Jilin Cancer Hospital

Address:
City: Changchun
Zip: 130012
Country: China

Facility:
Name: Beijing Cancer Hospital - PPDS

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Beijing Chest Hospital, Capital Medical Univerity

Address:
City: Beijing
Zip: 101149
Country: China

Facility:
Name: Icahn School of Medicine at Mount Sinai

Address:
City: Beijing
Country: China

Facility:
Name: Sichuan Cancer Hospital & Institute

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Guangdong Provincial People's Hospital

Address:
City: Guangzhou
Zip: 510080
Country: China

Facility:
Name: The First Affiliated Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310003
Country: China

Facility:
Name: Harbin Medical University Tumor Hospital

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Shanghai East Hospital

Address:
City: Shanghai
Zip: 200123
Country: China

Facility:
Name: Hubei Cancer Hospital

Address:
City: Wuhan
Zip: 430079
Country: China

Facility:
Name: Centre Francois Baclesse

Address:
City: Caen
Zip: 14076
Country: France

Facility:
Name: CHU de Nantes - Hoptal Nord Laennec

Address:
City: Nantes
Zip: 44000
Country: France

Facility:
Name: Hopital Calmette

Address:
City: Lille
Zip: 59037
Country: France

Facility:
Name: Centre Leon Berard

Address:
City: Lyon
Zip: 69373
Country: France

Facility:
Name: Institut Gustave Roussy

Address:
City: Villejuif
Zip: 94805
Country: France

Facility:
Name: CHU de Grenoble

Address:
City: Grenoble
Zip: 38043
Country: France

Facility:
Name: Hopital Nord AP-HM

Address:
City: Marseille
Zip: 13915
Country: France

Facility:
Name: CRLC Val d'Aurelle - Paul Lamarque

Address:
City: Montpellier
Zip: 34298
Country: France

Facility:
Name: Hopital Tenon

Address:
City: Paris
Zip: 75020
Country: France

Facility:
Name: Nouvel Hopital Civil

Address:
City: Strasbourg
Zip: 67091
Country: France

Facility:
Name: Hopital Larrey

Address:
City: Toulouse
Zip: 31059
Country: France

Facility:
Name: Thoraxklinik-Heidelberg gGmbH

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: LMU Klinikum der Universitat Munchen

Address:
City: Munchen
Zip: 80336
Country: Germany

Facility:
Name: University Clinic Regensburg

Address:
City: Regensburg
Zip: 93053
Country: Germany

Facility:
Name: Universitatsklinikum Frankfurt

Address:
City: Frankfurt am Main
Zip: 60596
Country: Germany

Facility:
Name: Pius Hospital Oldenburg

Address:
City: Oldenburg
Zip: 26121
Country: Germany

Facility:
Name: Helios Klinikum Emil Von Behring

Address:
City: Berlin
Zip: 14165
Country: Germany

Facility:
Name: Sotiria Chest Hospital of Athens

Address:
City: Athens
Zip: 11527
Country: Greece

Facility:
Name: Bioclinic Thessaloniki (Galinos clinic)

Address:
City: Thessaloniki
Zip: 546 29
Country: Greece

Facility:
Name: Princess Margaret Hospital

Address:
City: Kowloon
Country: Hong Kong

Facility:
Name: Pamela Youde Nethersole Eastern Hospital

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: Queen Elizabeth Hospital (QEH)

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: Queen Mary Hospital - PPDS

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: Tuen Mun Hospital

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: Prince of Wales Hospital

Address:
City: Sha Tin
Country: Hong Kong

Facility:
Name: Soroka University Medical Centre

Address:
City: Beer Sheva
Zip: 84101
Country: Israel

Facility:
Name: Sheba Medical Center - PPDS

Address:
City: Ramat Gan
Zip: 52621
Country: Israel

Facility:
Name: AORN Dei Colli- Ospedale Monaldi Napoli

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

Address:
City: Meldola
Zip: 47014
Country: Italy

Facility:
Name: Istituto Nazionale Dei Tumori

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: Instituto Europeo Di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Address:
City: Orbassano
Zip: 10043
Country: Italy

Facility:
Name: Centro Di Riferimento Oncologico

Address:
City: Aviano
Zip: 33081
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Pisana

Address:
City: Pisa
Zip: 56124
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria di Parma

Address:
City: Parma
Zip: 43126
Country: Italy

Facility:
Name: Ospedale Santa Maria Delle Croci

Address:
City: Ravenna
Zip: 48121
Country: Italy

Facility:
Name: Fujita Health University Hospital

Address:
City: Toyoake-Shi
Zip: 470-1101
Country: Japan

Facility:
Name: Ehime University Hospital

Address:
City: Matsuyama-Shi
Zip: 791-0280
Country: Japan

Facility:
Name: National Hospital Organization Hokkaido Cancer Center

Address:
City: Sapporo-Shi
Zip: 003-0804
Country: Japan

Facility:
Name: Kurume University Hospital

Address:
City: Kurume-Shi
Zip: 830-0011
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Yokohama-Shi
Zip: 241-0815
Country: Japan

Facility:
Name: Saiseikai Kumamoto Hospital

Address:
City: Kumamoto-Shi
Zip: 861-4101
Country: Japan

Facility:
Name: Miyagi Cancer Center

Address:
City: Natori-Shi
Zip: 981-1239
Country: Japan

Facility:
Name: Okayama University Hospital

Address:
City: Okayama-Shi
Zip: 700-0914
Country: Japan

Facility:
Name: Osaka International Cancer Institute

Address:
City: Chuo Ku
Zip: 540-0008
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Komoro
Zip: 362-0806
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-Shi
Zip: 277-0882
Country: Japan

Facility:
Name: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Address:
City: Koto-Ku
Zip: 135-0063
Country: Japan

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Pusan National University Hospital

Address:
City: Busan
Zip: 602-739
Country: Korea, Republic of

Facility:
Name: National Cancer Center

Address:
City: Goyang
Zip: 410769
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Jeongnam
Zip: 519-763,
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Asan Medical Center - PPDS

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center PPDS

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, Seoul St. Mary's Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Severance Hospital Yonsei University Health System - PPDS

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Facility:
Name: VU Medisch Centrum

Address:
City: Amsterdam
Zip: 1081 HV
Country: Netherlands

Facility:
Name: Centro Hospitalar do Porto Hospital de Santo Antonio

Address:
City: Santa Maria Da Feira
Zip: 4520-211
Country: Portugal

Facility:
Name: Hospital Cuf Porto

Address:
City: Vila Nova de Gaia
Zip: 4434-502
Country: Portugal

Facility:
Name: Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente

Address:
City: Lisboa
Zip: 1769-001
Country: Portugal

Facility:
Name: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

Address:
City: Porto
Zip: 4200-072
Country: Portugal

Facility:
Name: Centro Hospitalar de Sao Joao, E.P.E.

Address:
City: Porto
Zip: 4200
Country: Portugal

Facility:
Name: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

Address:
City: Saint Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: LLC "EuroCityClinic"

Address:
City: Saint Petersburg
Zip: 197022
Country: Russian Federation

Facility:
Name: National Cancer Centre

Address:
City: Singapore
Zip: 169608
Country: Singapore

Facility:
Name: ICO lHospitalet Hospital Duran i Reynals

Address:
City: L'Hospitalet de Llobregat
Zip: 08907
Country: Spain

Facility:
Name: Hospital Universitario A Coruna

Address:
City: A Coruna
Zip: 15006
Country: Spain

Facility:
Name: Hospital General Universitario de Alicante

Address:
City: Alicante
Zip: 03010
Country: Spain

Facility:
Name: Hospital Universitario Vall d'Hebron - PPDS

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: C.H. Regional Reina Sofia - PPDS

Address:
City: Cordoba
Zip: 14004
Country: Spain

Facility:
Name: Hospital Universitario Fundacion Jimenez Diaz

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Universitario La Paz - PPDS

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hospital Universitari i Politecnic La Fe de Valencia

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Karolinska Universitetssjukhuset Solna

Address:
City: Stockholm
Country: Sweden

Facility:
Name: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Address:
City: Dalin
Zip: 622
Country: Taiwan

Facility:
Name: National Taiwan University Hospital - YunLin Branch

Address:
City: Douliu
Zip: 640
Country: Taiwan

Facility:
Name: Kaohsiung Medical University - Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: E-DA hospital

Address:
City: Kaohsiung
Zip: 82445
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital

Address:
City: Taichung City
Zip: 407
Country: Taiwan

Facility:
Name: Chi Mei Medical Center, Liouying

Address:
City: Tainan City
Zip: 736
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 112
Country: Taiwan

Facility:
Name: Baskent University Medical Faculty Adana Practice and Research Center

Address:
City: Yuregir
Zip: 01120
Country: Turkey

Facility:
Name: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Address:
City: Kadikoy
Zip: 34772
Country: Turkey

Facility:
Name: Ege University Medical Faculty

Address:
City: Bornova
Zip: 35100
Country: Turkey

Facility:
Name: SAKARYA University Medical Faculty

Address:
City: Karaman
Zip: 54290
Country: Turkey

Facility:
Name: Hacettepe University Medical Faculty

Address:
City: Ankara
Zip: 06100
Country: Turkey

Facility:
Name: Trakya University Medical Faculty

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

Address:
City: Dnipropetrovsk
Zip: 49102
Country: Ukraine

Facility:
Name: Communal Non-profit Enterprise Regional Center of Oncology

Address:
City: Kharkiv
Zip: 61070
Country: Ukraine

Facility:
Name: Private Enterprise Private Manufacturing Company Acinus

Address:
City: Kropyvnytskyi
Zip: 25006
Country: Ukraine

Facility:
Name: University College London Hospitals (UCLH)

Address:
City: London
Zip: NW1 2PG
Country: United Kingdom

Facility:
Name: Royal Marsden Hospital - Surrey

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Facility:
Name: Clatterbridge Centre For Oncology

Address:
City: Bebington
Zip: CH63 4JY
Country: United Kingdom

Facility:
Name: Leicester General Hospital

Address:
City: Leicester
Zip: LE1 5WW
Country: United Kingdom

Facility:
Name: The Christie NHS Foundation Trust - PPDS

Address:
City: Manchester
Zip: M20 4GJ
Country: United Kingdom

Start date: January 10, 2020

Completion date: December 30, 2024

Lead sponsor:
Agency: Takeda
Agency class: Industry

Source: Takeda

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04129502