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

Primary Purpose

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

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAK-788
Pemetrexed
Cisplatin
Carboplatin
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 P-450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before randomization
  • 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.

Sites / Locations

  • UC San Diego Moores Cancer Center
  • City of Hope National Medical Center
  • California Research Institute
  • University of California Irvine
  • Stanford University
  • Eastern CT Hematology and Oncology Associates
  • AdventHealth
  • Northwestern University
  • University of Maryland Greenebaum Cancer Center
  • Beth Israel Deaconess Medical Center - 330 Brookline Ave
  • Dana Farber Cancer Institute
  • Massachusetts General Hospital
  • Icahn School of Medicine at Mount Sinai
  • Fox Chase Cancer Center
  • Sarah Cannon Cancer Center
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
  • University of Virginia Health System
  • St George Hospital
  • GenesisCare North Shore
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • Royal Hobart Hospital
  • Medizinische Universitat Graz
  • Klinik Floridsdorf
  • Cliniques Universitaires Saint-Luc
  • Grand Hopital de Charleroi asbl
  • AZ Sint-Lucas
  • British Columbia Cancer Agency
  • William Osler Health System
  • Princess Margaret Hospital
  • Hopital Du Sacre Coeur de Montreal
  • Beijing Cancer Hospital - PPDS
  • Henan Cancer Hospital
  • Jilin Cancer Hospital
  • Beijing Cancer Hospital - PPDS
  • Beijing Chest Hospital, Capital Medical Univerity
  • Sichuan Cancer Hospital & Institute
  • Guangdong Provincial People's Hospital
  • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Harbin Medical University Tumor Hospital
  • The Second Affiliated Hospital of Nanchang University
  • Shanghai East Hospital
  • Hubei Cancer Hospital
  • Copenhagen University Hospital
  • Odense Universitetshospital
  • Centre Francois Baclesse
  • CHU de Nantes - Hoptal Nord Laennec
  • Hopital Calmette
  • Hopital Louis Pradel
  • Centre Leon Berard
  • Institut Gustave Roussy
  • Centre Hospitalier Intercommunal
  • CHU de Grenoble
  • Hopital Nord AP-HM
  • CRLC Val d'Aurelle - Paul Lamarque
  • Hopital Tenon
  • Hopital PONTCHAILLOU CHU de Rennes
  • Nouvel Hopital Civil
  • Hopital Larrey
  • Klinik Schillerhohe
  • Thoraxklinik-Heidelberg gGmbH
  • LMU Klinikum der Universitat Munchen
  • University Clinic Regensburg
  • Universitatsklinikum Frankfurt
  • Pius Hospital Oldenburg
  • Stadtischen Krankenhaus Kiel
  • Helios Klinikum Emil Von Behring
  • Malteser Krankenhaus St. Franziskus-Hospital
  • Asklepios Fachkliniken GmbH
  • Sotiria Chest Hospital of Athens
  • Metaxa Cancer Hospital of Piraeus
  • Bioclinic Thessaloniki (Galinos clinic)
  • Princess Margaret Hospital
  • Pamela Youde Nethersole Eastern Hospital
  • Queen Elizabeth Hospital (QEH)
  • Queen Mary Hospital - PPDS
  • Tuen Mun Hospital
  • Prince of Wales Hospital
  • Soroka University Medical Centre
  • Rambam Medical Center PPDS
  • Meir Medical Center
  • Sheba Medical Center - PPDS
  • AORN Dei Colli- Ospedale Monaldi Napoli
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
  • Istituto Nazionale Dei Tumori
  • Instituto Europeo Di Oncologia
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
  • Centro Di Riferimento Oncologico
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliero Universitaria di Parma
  • Ospedale Santa Maria Delle Croci
  • Fujita Health University Hospital
  • Ehime University Hospital
  • Hiroshima University Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Kurume University Hospital
  • Kanagawa Cancer Center
  • Saiseikai Kumamoto Hospital
  • Miyagi Cancer Center
  • Okayama University Hospital
  • Osaka International Cancer Institute
  • Osaka Metropolitan University Hospital
  • Kindai University Hospital
  • Saitama Cancer Center
  • National Cancer Center Hospital East
  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • National Hospital Organization Yamaguchi-Ube Medical Center
  • Chungbuk National University Hospital
  • Pusan National University Hospital
  • National Cancer Center
  • Chonnam National University Hwasun Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Asan Medical Center - PPDS
  • Samsung Medical Center PPDS
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Severance Hospital Yonsei University Health System - PPDS
  • VU Medisch Centrum
  • Centro Hospitalar do Porto Hospital de Santo Antonio
  • Hospital Cuf Porto
  • Fundacao Champalimaud
  • Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
  • Centro Hospitalar de Sao Joao, E.P.E.
  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
  • LLC "EuroCityClinic"
  • Moscow City Oncology Hospital #62
  • Scientific Research Institute of Oncology n.a. N.N. Petrov
  • National Cancer Centre
  • ICO lHospitalet Hospital Duran i Reynals
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Universitario A Coruna
  • Hospital General Universitario de Alicante
  • Hospital Universitario Vall d'Hebron - PPDS
  • Hospital Clinic de Barcelona
  • C.H. Regional Reina Sofia - PPDS
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz - PPDS
  • Hospital Regional Universitario de Malaga Hospital General
  • Hospital Universitario Virgen del Rocio - PPDS
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Karolinska Universitetssjukhuset Solna
  • Sahlgrenska Universitetssjukhuset
  • Universitatsspital Basel
  • Kantonsspital Winterthur
  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • National Taiwan University Hospital - YunLin Branch
  • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • E-DA hospital
  • Taichung Veterans General Hospital
  • Chi Mei Medical Center, Liouying
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Baskent University Medical Faculty Adana Practice and Research Center
  • Istanbul University Cerrahpasa Medical Faculty Hospital
  • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Ege University Medical Faculty
  • Kocaeli University Hospital
  • SAKARYA University Medical Faculty
  • Hacettepe University Medical Faculty
  • Trakya University Medical Faculty
  • Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
  • Municipal Non-profit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC
  • Communal Non-profit Enterprise Regional Center of Oncology
  • Private Enterprise Private Manufacturing Company Acinus
  • Velindre Cancer Centre - PPDS
  • University College London Hospitals (UCLH)
  • The Royal Marsden - London
  • Royal Marsden Hospital - Surrey
  • Clatterbridge Centre For Oncology
  • Leicester General Hospital
  • The Christie NHS Foundation Trust - PPDS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAK-788 Group (Arm A)

Platinum-based Chemotherapy Group (Arm B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST Version 1.1 are met or death, whichever occurs first.

Secondary Outcome Measures

Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved complete response (CR) or partial response (PR). Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.
Overall Survival (OS)
OS is defined as the interval from the date of randomization until death.
Progression Free Survival (PFS) as Assessed by the Investigator
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST Version 1.1 are met or death, whichever occurs first.
Confirmed Objective Response Rate (ORR) as Assessed by the Investigator
Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved CR or PR. Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.
Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD or death (whichever occurs first) is objectively documented.
Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
Time to response is defined as the time interval from the date of randomization until the initial observation of CR or PR.
Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study drug.
Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).
Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13)
EORTC QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Raw scores will be converted into scale scores ranging from 0 to 100. Higher scores represent a high level of symptomatology/problems.

Full Information

First Posted
October 7, 2019
Last Updated
April 6, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04129502
Brief Title
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
February 20, 2026 (Anticipated)
Study Completion Date
June 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAK-788 Group (Arm A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Platinum-based Chemotherapy Group (Arm B)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAK-788
Other Intervention Name(s)
AP32788, Mobocertinib
Intervention Description
TAK-788 capsule
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
Pemetrexed IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin IV infusion
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST Version 1.1 are met or death, whichever occurs first.
Time Frame
Up to approximately 40 months after the first participant is randomized
Secondary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Description
Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved complete response (CR) or partial response (PR). Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Overall Survival (OS)
Description
OS is defined as the interval from the date of randomization until death.
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Progression Free Survival (PFS) as Assessed by the Investigator
Description
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST Version 1.1 are met or death, whichever occurs first.
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Confirmed Objective Response Rate (ORR) as Assessed by the Investigator
Description
Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved CR or PR. Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
Description
Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD or death (whichever occurs first) is objectively documented.
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
Description
Time to response is defined as the time interval from the date of randomization until the initial observation of CR or PR.
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
Description
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study drug.
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Description
EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).
Time Frame
Up to approximately 40 months after the first participant is randomized
Title
Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13)
Description
EORTC QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Raw scores will be converted into scale scores ranging from 0 to 100. Higher scores represent a high level of symptomatology/problems.
Time Frame
Up to approximately 40 months after the first participant is randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
City of Hope National Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
California Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Eastern CT Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
AdventHealth
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconess Medical Center - 330 Brookline Ave
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2137
Country
Australia
Facility Name
GenesisCare North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Medizinische Universitat Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinik Floridsdorf
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital de Charleroi asbl
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Sint-Lucas
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z-4E6
Country
Canada
Facility Name
William Osler Health System
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Hopital Du Sacre Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Beijing Cancer Hospital - PPDS
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Beijing Cancer Hospital - PPDS
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Chest Hospital, Capital Medical Univerity
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Sichuan Cancer Hospital & Institute
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Harbin Medical University Tumor Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200123
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Centre Francois Baclesse
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
CHU de Nantes - Hoptal Nord Laennec
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital Calmette
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Louis Pradel
City
Bron
State/Province
Rhone
ZIP/Postal Code
69500
Country
France
Facility Name
Centre Leon Berard
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Nord AP-HM
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
CRLC Val d'Aurelle - Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hopital PONTCHAILLOU CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Klinik Schillerhohe
City
Gerlingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
70839
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
LMU Klinikum der Universitat Munchen
City
Munchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
University Clinic Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Pius Hospital Oldenburg
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26121
Country
Germany
Facility Name
Stadtischen Krankenhaus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24116
Country
Germany
Facility Name
Helios Klinikum Emil Von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Malteser Krankenhaus St. Franziskus-Hospital
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
Facility Name
Asklepios Fachkliniken GmbH
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Sotiria Chest Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metaxa Cancer Hospital of Piraeus
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
185 37
Country
Greece
Facility Name
Bioclinic Thessaloniki (Galinos clinic)
City
Thessaloniki
ZIP/Postal Code
546 29
Country
Greece
Facility Name
Princess Margaret Hospital
City
Kowloon
State/Province
Kowloon City
Country
Hong Kong
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital (QEH)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital - PPDS
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Sha Tin
Country
Hong Kong
Facility Name
Soroka University Medical Centre
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center PPDS
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Sheba Medical Center - PPDS
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
AORN Dei Colli- Ospedale Monaldi Napoli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Nazionale Dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Instituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Centro Di Riferimento Oncologico
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Ospedale Santa Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Fujita Health University Hospital
City
Toyoake-Shi
State/Province
Aiti
ZIP/Postal Code
470-1101
Country
Japan
Facility Name
Ehime University Hospital
City
Matsuyama-Shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-Shi
State/Province
Hirosima
ZIP/Postal Code
734-0037
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo-Shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-Shi
State/Province
Hukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto-Shi
State/Province
Kumamoto
ZIP/Postal Code
861-4101
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori-Shi
State/Province
Miyagi
ZIP/Postal Code
981-1239
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-Shi
State/Province
Okayama
ZIP/Postal Code
700-0914
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Chuo Ku
State/Province
Osaka
ZIP/Postal Code
540-0008
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-Shi
State/Province
Osaka
ZIP/Postal Code
589-0014
Country
Japan
Facility Name
Saitama Cancer Center
City
Komoro
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa-Shi
State/Province
Tiba
ZIP/Postal Code
277-0882
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
135-0063
Country
Japan
Facility Name
National Hospital Organization Yamaguchi-Ube Medical Center
City
Ube-Shi
State/Province
Yamaguti
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbugdo
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
ZIP/Postal Code
410769
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeongnam
ZIP/Postal Code
519-763,
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center PPDS
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
VU Medisch Centrum
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Centro Hospitalar do Porto Hospital de Santo Antonio
City
Santa Maria Da Feira
State/Province
Aveiro
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Hospital Cuf Porto
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Fundacao Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao, E.P.E.
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
LLC "EuroCityClinic"
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Scientific Research Institute of Oncology n.a. N.N. Petrov
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
ICO lHospitalet Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
C.H. Regional Reina Sofia - PPDS
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga Hospital General
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
State/Province
Sodermanlands Lan
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Universitatsspital Basel
City
Basel
State/Province
Basel-Stadt (de)
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Dalin
ZIP/Postal Code
622
Country
Taiwan
Facility Name
National Taiwan University Hospital - YunLin Branch
City
Douliu
ZIP/Postal Code
640
Country
Taiwan
Facility Name
Kaohsiung Medical University - Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
E-DA hospital
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung City
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Chi Mei Medical Center, Liouying
City
Tainan City
ZIP/Postal Code
736
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Baskent University Medical Faculty Adana Practice and Research Center
City
Yuregir
State/Province
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty Hospital
City
Fatih
State/Province
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
City
Kadikoy
State/Province
Istanbul
ZIP/Postal Code
34772
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Kocaeli University Hospital
City
Izmit
State/Province
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
SAKARYA University Medical Faculty
City
Karaman
State/Province
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
City
Dnipropetrovsk
State/Province
Dnipropetrovs'ka Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC
City
Ivano-Frankivsk
State/Province
Ivano-Frankivs'ka Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal Non-profit Enterprise Regional Center of Oncology
City
Kharkiv
State/Province
Kharkivs'ka Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Private Enterprise Private Manufacturing Company Acinus
City
Kropyvnytskyi
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Velindre Cancer Centre - PPDS
City
Whitchurch
State/Province
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
University College London Hospitals (UCLH)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Royal Marsden - London
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Surrey
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Clatterbridge Centre For Oncology
City
Bebington
State/Province
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust - PPDS
City
Manchester
ZIP/Postal Code
M20 4GJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

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

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