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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05338970




Registration number
NCT05338970
Ethics application status
Date submitted
15/04/2022
Date registered
21/04/2022

Titles & IDs
Public title
HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
Scientific title
A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy (HERTHENA-Lung02)
Secondary ID [1] 0 0
2021-005879-40
Secondary ID [2] 0 0
U31402-A-U301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonsquamous Non-small Cell Lung Cancer 0 0
EGFR L858R 0 0
EGFR Exon 19 Deletion 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Patritumab Deruxtecan
Treatment: Drugs - Platinum-based chemotherapy

Experimental: Patritumab deruxtecan - Participants who will be randomized to receive patritumab deruxtecan (HER3-DXd) 5.6 mg/kg q3W.

Active comparator: Platinum-based chemotherapy - Participants who will be randomized to receive platinum-based chemotherapy for 4 cycles: pemetrexed plus either cisplatin or carboplatin. Participants without disease progression after 4 cycles of platinum plus pemetrexed therapy may continue treatment with maintenance pemetrexed with no restriction on the number of cycles.


Treatment: Drugs: Patritumab Deruxtecan
Intravenous administration, 5.6 mg/kg every 3 weeks (q3W)

Treatment: Drugs: Platinum-based chemotherapy
Intravenous, pemetrexed 500 mg/m\^2 plus either cisplatin (75 mg/m\^2) or carboplatin (target area under the plasma concentration time curve of 5 \[AUC5\] by using the Calvert formula) q3W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1
Timepoint [1] 0 0
Baseline up to approximately 49 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline up to approximately 49 months
Secondary outcome [2] 0 0
Progression-free Survival (PFS) as Assessed by Investigator Review Based on RECIST v1.1
Timepoint [2] 0 0
Baseline up to approximately 49 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS) as Assessed by Local Standard Clinical Practice
Timepoint [3] 0 0
Baseline up to approximately 49 months
Secondary outcome [4] 0 0
Objective Response Rate (ORR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Timepoint [4] 0 0
Baseline up to approximately 49 months
Secondary outcome [5] 0 0
Duration of Response (DoR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Timepoint [5] 0 0
Baseline up to approximately 49 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Timepoint [6] 0 0
Baseline up to approximately 49 months
Secondary outcome [7] 0 0
Disease Control Rate (DCR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Timepoint [7] 0 0
Baseline up to approximately 49 months
Secondary outcome [8] 0 0
Time to Response (TTR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Timepoint [8] 0 0
Baseline up to approximately 49 months
Secondary outcome [9] 0 0
Intracranial PFS as Assessed by BICR
Timepoint [9] 0 0
Baseline up to approximately 49 months
Secondary outcome [10] 0 0
Mean Change from Baseline in Non-small Cell Lung Cancer - Symptom Assessment Questionnaire
Timepoint [10] 0 0
Baseline up to approximately 49 months
Secondary outcome [11] 0 0
Mean Change from Baseline in Patient's Global Impression of Change
Timepoint [11] 0 0
Baseline up to approximately 49 months
Secondary outcome [12] 0 0
Mean Change from Baseline in Patient's Global Impression of Severity
Timepoint [12] 0 0
Baseline up to approximately 49 months
Secondary outcome [13] 0 0
Mean Change from Baseline in Patient's Global Impression of Treatment Tolerability
Timepoint [13] 0 0
Baseline up to approximately 49 months
Secondary outcome [14] 0 0
Mean Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Timepoint [14] 0 0
Baseline up to approximately 49 months
Secondary outcome [15] 0 0
Mean Change from Baseline in EuroQol Questionnaire-5 dimensions-5 levels (EQ-5D-5L)
Timepoint [15] 0 0
Baseline up to approximately 49 months
Secondary outcome [16] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [16] 0 0
Baseline up to approximately 49 months
Secondary outcome [17] 0 0
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
Timepoint [17] 0 0
Baseline up to approximately 49 months
Secondary outcome [18] 0 0
Percentage of Participants Who Have Treatment-emergent ADA
Timepoint [18] 0 0
Baseline up to approximately 49 months

Eligibility
Key inclusion criteria
1. Is a male or female subject aged =18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
2. Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation.
3. Has documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter.
4. Received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a third -generation EGFR TKI
5. May have received either neoadjuvant and/or adjuvant treatment if progression to metastatic or locally advanced disease occurred at least 12 months after the last dose of such therapy and subsequently experienced disease progression on or after third-generation EGFR TKI treatment administered in the metastatic or locally advanced setting.
6. Has not received any other prior systemic therapies in the metastatic or locally advanced setting (including chemotherapy, immunotherapy etc) (even if administered in combination with EGFR TKI).
7. Has documentation of radiographic disease progression while receiving or after receiving a third generation EGFR TKI for metastatic or locally advanced disease.
8. Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment.
9. Is willing to have a tumor biopsy or provide recently obtained tumor tissue.
10. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
11. Has adequate bone marrow reserve and organ function based on local laboratory evaluation within 14 days prior to randomization:

* Platelet count: =100,000/mm^3 or =100 × 10^9/L within 14 days prior to the assessment of platelet count during the Screening Period
* Absolute neutrophil count: =1500/mm^3 or =1.5 × 10^9/L within 14 days prior to the assessment of absolute neutrophil count during the Screening Period
* Hemoglobin (Hgb): =9.0 g/dL within 14 days prior to the assessment of hemoglobin during the Screening Period
* Creatine clearance (CrCl): CrCl =45 mL/min calculated by using the Cockcroft-Gault equation or measured CrCl
* Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): AST/ALT =3× Upper limit of normal (ULN)
* Total bilirubin (TBL): TBL =1.5 × ULN
* Serum albumin: =2.5 g/dL
* Prothrombin time (PT) or Prothrombin time-International normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT): =1.5 × ULN, except for participants receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy who must have PT-INR within therapeutic range as deemed appropriate by the Investigator
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy, or squamous NSCLC histology
2. Has any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during Screening
3. Has clinically severe respiratory compromise (based on the Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to the following:

* Any underlying pulmonary disorder, restrictive lung disease, or pleural effusion
* Any autoimmune, connective tissue, or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of Screening
* OR prior complete pneumonectomy
4. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization
5. Has any history of or evidence of current leptomeningeal disease
6. Has evidence of clinically active spinal cord compression or brain metastases, defined as being symptomatic and untreated, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
7. Any prior treatment with any agent including an antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I, human epidermal growth factor receptor 3 (HER3) antibody, and any systemic therapies (other than EGFR TKIs) in the metastatic/locally advanced setting, including chemotherapy or any other systemic therapy in combination with an EGFR TKI
8. Has history of other active malignancy within 3 years prior to randomization, except for adequately resected nonmelanoma skin cancer, adequately treated intraepithelial carcinoma of the cervix, and any other curatively treated in situ disease
9. Has uncontrolled or significant cardiovascular disease prior to randomization
10. Has active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of randomization
11. Has a known human immunodeficiency virus (HIV) infection that is not well controlled
12. Has clinically significant corneal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
Accrual to date
Final
586
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St George Public Hospital - Kogarah
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Austin Hospital - Melbourne
Recruitment hospital [5] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3084 - Melbourne
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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Idaho
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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New Hampshire
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United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
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Virginia
Country [16] 0 0
United States of America
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Wisconsin
Country [17] 0 0
Austria
State/province [17] 0 0
Feldkirch
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Austria
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Innsbruck
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Austria
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Klagenfurt
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Austria
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Wels
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Leuven
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Belgium
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Mechelen
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Belgium
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Roeselare
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Canada
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Brampton
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China
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Beijing
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China
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Chang chun
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China
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Changsha
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Chengdu
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Chibi
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Fuzhou
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Guangzhou
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China
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Haidian
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China
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Hangzhou
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Harbin
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Hefei
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Henan
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Kunming
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Linyi
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Nanjing
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Nanning
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Shantou
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Wuhan
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Xi'an
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Zhengzhou
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Ürümqi
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France
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Brest
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Caen
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Paris
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Rennes
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Villejuif
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Germany
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Essen
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Esslingen
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Frankfurt am main
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Gauting
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Germany
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Gießen
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Germany
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Großhansdorf
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Germany
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Heidelberg
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Germany
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Immenhausen
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Germany
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Kempten
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Germany
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Oldenburg
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Hong Kong
State/province [70] 0 0
Hong Kong
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Italy
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Bari
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Italy
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Chieti
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Italy
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Lucca
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Italy
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Milano
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Italy
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Orbassano
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Parma
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Italy
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Perugia
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Varese
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Japan
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Akashi
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Japan
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Fukuoka
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Japan
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Hidaka
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Japan
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Hirakata
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Iwakuni
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Izumi
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Kanazawa
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Koto-Ku
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Kumamoto
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Japan
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Kurashiki
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Japan
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Kurume
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Japan
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Matsusaka
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Japan
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Matsuyama
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Japan
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Nagoya
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Niigata
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Okayama
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Sapporo
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Sendai
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Tokyo
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Toyoake
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Wakayama
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Osaka-sayama
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Korea, Republic of
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Cheongju-si
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Goyang
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Arnhem
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Harderwijk
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Leiden
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Rotterdam
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Utrecht
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Nordbyhagen
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Oslo
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Stavanger
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Poland
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Bialystok
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Lublin
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Poznan
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Singapore
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Singapore
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Las Palmas De Gran Canaria
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Santander
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Spain
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Sevilla
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Switzerland
State/province [130] 0 0
Chur
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Switzerland
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Winterthur
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taoyuan
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Birmingham
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Glasgow
Country [139] 0 0
United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05338970