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HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Primary Purpose

Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Patritumab Deruxtecan
Platinum-based chemotherapy
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsquamous Non-small Cell Lung Cancer focused on measuring Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR exon 19 deletion, Patritumab deruxtecan, HER3-DXd, U3-1402

Eligibility Criteria

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

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
    • Absolute neutrophil count: ≥1500/mm^3 or ≥1.5 × 10^9/L
    • Hemoglobin (Hgb): ≥9.0 g/dL
    • 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

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 evidence of any 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

Sites / Locations

  • Alaska Oncology and Hematology LLCRecruiting
  • Highlands OncologyRecruiting
  • City of HopeRecruiting
  • Moores Cancer Center at the UC San Diego HealthRecruiting
  • Scripps MD Anderson Cancer CenterRecruiting
  • USC Norris Comprehensive Cancer CenterRecruiting
  • Kaiser Permanente - Vallejo Medical CenterRecruiting
  • Innovative Clinical Research InstituteRecruiting
  • Sarah Cannon/Florida Cancer Specialists - FCS SouthRecruiting
  • Emory UniversityRecruiting
  • St Luke's Cancer InstituteRecruiting
  • The University of Chicago
  • American Oncology Partners of MarylandRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • Hackensack Meridian Health-Southern Ocean Medical CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • Inova Schar Cancer InstituteRecruiting
  • Virginia Cancer SpecialistsRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • The Chris O'Brien LifehouseRecruiting
  • St George Public HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Austin HospitalRecruiting
  • St John of God Subiaco HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Landeskrankenhaus FeldkirchRecruiting
  • Medizinische Universitaet InnsbruckRecruiting
  • Klinikum Klagenfurt PulmologieRecruiting
  • Klinikum Wels-GrieskirchenRecruiting
  • Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik FloridsdorfRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • UZ LeuvenRecruiting
  • AZ Sint Maarten MechelenRecruiting
  • AZ DeltaRecruiting
  • William Osler Health System - Brampton Civic HospitalRecruiting
  • Sunnybrook Health Sciences Ctr
  • Peking University Cancer HospitalRecruiting
  • Jilin Cancer Hospital
  • Hunan Cancer HospitalRecruiting
  • University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital
  • National Cancer Center Hospital EastRecruiting
  • Fujian Medical University - Union Hospital Foochow Christian Union HospitalRecruiting
  • Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples HospitalRecruiting
  • The First Affiliated Hospital Sun-Yat-Sen UniversityRecruiting
  • Pecking University Third HospitalRecruiting
  • The First Affiliated Hospital of College of Medicine Zhejiang UniversityRecruiting
  • Zhejiang Cancer hospitalRecruiting
  • Harbin Medical University - Tumor Hospital The Third Affiliated HospitalRecruiting
  • The First Affiliated Hospital - Anhui Medical University Dept of Medical OncologyRecruiting
  • Henan Provincial Peoples HospitalRecruiting
  • The Second Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Lin Yi Cancer HospitalRecruiting
  • General Hospital of Eastern Theater CommandRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • Fudan University - Shanghai Cancer Center FUSCCRecruiting
  • Cancer Hospital of Shantou University Medical CollegeRecruiting
  • The First Hospital of China Medical UniversityRecruiting
  • Liaoning Cancer Hospital & Institute
  • Union Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
  • The First Affiliate Hospital of Xi'an Jiaotong UniversityRecruiting
  • Henan Cancer HospitalRecruiting
  • Affiliated Cancer Hospital of Xinjiang Medical UniversityRecruiting
  • Hopital Morvan CHU de BrestRecruiting
  • Centre Francois BaclesseRecruiting
  • Centre Francois Baclesse
  • Centre Leon BerardRecruiting
  • Montpellier Cancer Institute ICMRecruiting
  • Institut CurieRecruiting
  • APHP - Hopital Saint LouisRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de PontchaillouRecruiting
  • Institut de Cancrologie de lOuest ICORecruiting
  • Gustave RoussyRecruiting
  • Universitaetsklinikum EssenRecruiting
  • Klinikum Esslingen GmbHRecruiting
  • IKF Krankenhaus NordwestRecruiting
  • Asklepios Fachklinik Muenchen-GautingRecruiting
  • Universitatsklinik Giessen und MarburgRecruiting
  • LungenClinic GrosshansdorfRecruiting
  • Thoraxklinik Heidelberg gGmbHRecruiting
  • LKI Lungenfachklinik ImmenhausenRecruiting
  • Klinikverbund AllgaeuRecruiting
  • Klinikum Nuernberg Nord
  • Pius-Hospital OldenburgRecruiting
  • Universitaetsklinikum Wurzburg
  • Pamela Youde Nethersole Eastern Hospital
  • Prince of Wales HospitalRecruiting
  • University of Hong Kong/Queen Mary HospitalRecruiting
  • Queen Elizabeth HospitalRecruiting
  • IRCCS Istituto Oncologico Giovanni Paolo IIRecruiting
  • University G. D'Annunzio ChietiRecruiting
  • Ospedale San LucaRecruiting
  • IRCCS Istituto Europeo di OncologiaRecruiting
  • Asst Grande Ospedale Metropolitano NiguardaRecruiting
  • Azienda Ospedaliero-Universitaria San Luigi GonzagaRecruiting
  • Azienda Ospedaliero Universitaria di ParmaRecruiting
  • Ospedale Santa Maria della MisericordiaRecruiting
  • IFO Regina ElenaRecruiting
  • IRCCS Humanitas Research HospitalRecruiting
  • ASST Sette LaghiRecruiting
  • Hyogo Cancer CenterRecruiting
  • Kyushu University HospitalRecruiting
  • Saitama Medical University International Medical CenterRecruiting
  • Kansai Medical University HospitalRecruiting
  • Iwakuni Clinical CenterRecruiting
  • Izumi City General HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • The Cancer Institute Hospital of JFCRRecruiting
  • Saiseikai Kumamoto HospitalRecruiting
  • Kurashiki Central HospitalRecruiting
  • Kurume University HospitalRecruiting
  • Matsusaka Municipal HospitalRecruiting
  • NHO Shikoku Cancer CenterRecruiting
  • National Hospital Organization Nagoya Medical CenterRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Okayama University HospitalRecruiting
  • National Hospital Organization Hokkaido Cancer CenterRecruiting
  • Sendai Kousei HospitalRecruiting
  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalRecruiting
  • Fujita Health University HospitalRecruiting
  • Wakayama Medical University HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea, Seoul St. Marys HospitalRecruiting
  • Samsung Medical Center
  • Netherlands Cancer Institute
  • Rijnstate ZiekenhuisRecruiting
  • St. Jansdal ZiekenhuisRecruiting
  • Leiden University Medical CenterRecruiting
  • Erasmus MC
  • University Medical Center UtrechtRecruiting
  • Akershus University HospitalRecruiting
  • Oslo University Hospital-The Norwegian Radium HospitalRecruiting
  • Stavanger University HospitalRecruiting
  • II Klinika Chorob Pluc i GruzlicyRecruiting
  • Onko-Centrum Sp. z o.o.Recruiting
  • Med Polonia Sp. z o.o.Recruiting
  • Centro Clinico ChampalimaudRecruiting
  • Instituto Portugues de Oncologio de LisboaRecruiting
  • Centro Hospitalar Universitario do Porto - Hospital de Santo AntonioRecruiting
  • Centro Hospitalar de Vila Nova de Gaia - EspinhoRecruiting
  • National University Cancer Institute National University HospitalRecruiting
  • National Cancer Centre Singapore NCCSRecruiting
  • Tan Tock Seng HospitalRecruiting
  • ICON Cancer CentreRecruiting
  • Hospital Teresa Herrera C.H.U.A.C.Recruiting
  • Hospital del MarRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinic i Provincial de BarcelonaRecruiting
  • Complejo Hospitalario Materno-Insular - Hospital Insular de Gran CanariaRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Regional Universitario MalagaRecruiting
  • Hospital Univeritario Marques de ValdecillaRecruiting
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen MacarenaRecruiting
  • University Hospital Basel
  • Kantonsspital Graubuenden - HauptstandortRecruiting
  • Kantonsspital Winterthur KSWRecruiting
  • E-Da HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • National Cheng Kung University Hospital NCKUHRecruiting
  • National Taiwan University Hospital NTUHRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Memorial Hospital-Linkou BranchRecruiting
  • University Hospital Birmingham NHS TrustRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • Leeds Cancer CentreRecruiting
  • University Hospitals of LeicesterRecruiting
  • Barts and The London NHS Trust - St Bartholomew s hospital - PET CT CentreRecruiting
  • The Royal Marsden Hospital NHS Foundation TrustRecruiting
  • The Royal Marsden NHS Foundation TrustRecruiting
  • The Christie HospitalRecruiting
  • The Royal Wolverhampton NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patritumab deruxtecan

Platinum-based chemotherapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.

Secondary Outcome Measures

Overall Survival (OS)
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
Progression-free Survival (PFS) as Assessed by Investigator Review Based on RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.
Progression-free Survival (PFS) as Assessed by Local Standard Clinical Practice
Progression-free survival (PFS) by local standard clinical practice is defined as the time from date of randomization to the documented progression on the first new anticancer therapy (if administered) or death due to any cause, whichever occurred first.
Objective Response Rate (ORR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Objective response rate (ORR) is defined as the proportion of participants who have a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).
Duration of Response (DoR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Duration of response (DoR) is defined as the time from the first documentation of objective response (CR or PR) to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Clinical benefit rate (CBR) will be assessed by BICR and Investigator based on RECIST v1.1. CBR is defined as the proportion of participants who have a confirmed BOR of CR, PR, or stable disease (SD) that lasts for at least 180 days.
Disease Control Rate (DCR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Disease control rate (DCR) is defined as the proportion of participants who have a confirmed BOR of CR, PR, or SD.
Time to Response (TTR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Time to response (TTR) is defined as the time from the date of randomization to the date of the first documentation of response (CR or PR) that is subsequently confirmed.
Mean Change from Baseline in Non-small Cell Lung Cancer - Symptom Assessment Questionnaire
The NSCLC-SAQ will assess disease-related symptom change in patients with NSCLC.
Mean Change from Baseline in Patient's Global Impression of Change
The PGI-C is a 7-point scale depicting a participant's rating of overall improvement.
Mean Change from Baseline in Patient's Global Impression of Severity
The PGI-S is a one-item questionnaire that contains six response options.
Mean Change from Baseline in Patient's Global Impression of Treatment Tolerability
The PGI-TT will capture the patient's overall impression of treatment tolerability.
Mean Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
The EORTC-QLQ-C30 will assess the patient's overall quality of life (QoL).
Mean Change from Baseline in EuroQol Questionnaire-5 dimensions-5 levels (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument that will be used for measuring generic health status required for health technology assessments.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs will be graded by using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
The immunogenicity of patritumab deruxtecan will be confirmed by assessing the anti-drug antibodies.
Percentage of Participants Who Have Treatment-emergent ADA
The immunogenicity of patritumab deruxtecan will be confirmed by assessing the anti-drug antibodies.

Full Information

First Posted
April 15, 2022
Last Updated
September 15, 2023
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05338970
Brief 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
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 4, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

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
Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.
Detailed Description
Patritumab deruxtecan (HER3-DXd, U3-1402) is an antibody-drug conjugate (ADC) comprising an anti-HER3 mAb linked to a topoisomerase I inhibitor that is in clinical development for patients with NSCLC, metastatic breast cancer, and colorectal cancer. The primary objective of the current study is to compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by progression-free survival (PFS) and the key secondary endpoint of overall survival (OS), in participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (eg, osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion
Keywords
Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR exon 19 deletion, Patritumab deruxtecan, HER3-DXd, U3-1402

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patritumab deruxtecan
Arm Type
Experimental
Arm Description
Participants who will be randomized to receive patritumab deruxtecan (HER3-DXd) 5.6 mg/kg q3W.
Arm Title
Platinum-based chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Patritumab Deruxtecan
Other Intervention Name(s)
HER3-DXd, U3-1402
Intervention Description
Intravenous administration, 5.6 mg/kg every 3 weeks (q3W)
Intervention Type
Drug
Intervention Name(s)
Platinum-based chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.
Time Frame
Baseline up to approximately 49 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
Baseline up to approximately 49 months
Title
Progression-free Survival (PFS) as Assessed by Investigator Review Based on RECIST v1.1
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.
Time Frame
Baseline up to approximately 49 months
Title
Progression-free Survival (PFS) as Assessed by Local Standard Clinical Practice
Description
Progression-free survival (PFS) by local standard clinical practice is defined as the time from date of randomization to the documented progression on the first new anticancer therapy (if administered) or death due to any cause, whichever occurred first.
Time Frame
Baseline up to approximately 49 months
Title
Objective Response Rate (ORR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Description
Objective response rate (ORR) is defined as the proportion of participants who have a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).
Time Frame
Baseline up to approximately 49 months
Title
Duration of Response (DoR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Description
Duration of response (DoR) is defined as the time from the first documentation of objective response (CR or PR) to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.
Time Frame
Baseline up to approximately 49 months
Title
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Description
Clinical benefit rate (CBR) will be assessed by BICR and Investigator based on RECIST v1.1. CBR is defined as the proportion of participants who have a confirmed BOR of CR, PR, or stable disease (SD) that lasts for at least 180 days.
Time Frame
Baseline up to approximately 49 months
Title
Disease Control Rate (DCR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Description
Disease control rate (DCR) is defined as the proportion of participants who have a confirmed BOR of CR, PR, or SD.
Time Frame
Baseline up to approximately 49 months
Title
Time to Response (TTR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Description
Time to response (TTR) is defined as the time from the date of randomization to the date of the first documentation of response (CR or PR) that is subsequently confirmed.
Time Frame
Baseline up to approximately 49 months
Title
Mean Change from Baseline in Non-small Cell Lung Cancer - Symptom Assessment Questionnaire
Description
The NSCLC-SAQ will assess disease-related symptom change in patients with NSCLC.
Time Frame
Baseline up to approximately 49 months
Title
Mean Change from Baseline in Patient's Global Impression of Change
Description
The PGI-C is a 7-point scale depicting a participant's rating of overall improvement.
Time Frame
Baseline up to approximately 49 months
Title
Mean Change from Baseline in Patient's Global Impression of Severity
Description
The PGI-S is a one-item questionnaire that contains six response options.
Time Frame
Baseline up to approximately 49 months
Title
Mean Change from Baseline in Patient's Global Impression of Treatment Tolerability
Description
The PGI-TT will capture the patient's overall impression of treatment tolerability.
Time Frame
Baseline up to approximately 49 months
Title
Mean Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Description
The EORTC-QLQ-C30 will assess the patient's overall quality of life (QoL).
Time Frame
Baseline up to approximately 49 months
Title
Mean Change from Baseline in EuroQol Questionnaire-5 dimensions-5 levels (EQ-5D-5L)
Description
The EQ-5D-5L is a standardized instrument that will be used for measuring generic health status required for health technology assessments.
Time Frame
Baseline up to approximately 49 months
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
TEAEs will be graded by using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Time Frame
Baseline up to approximately 49 months
Title
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
Description
The immunogenicity of patritumab deruxtecan will be confirmed by assessing the anti-drug antibodies.
Time Frame
Baseline up to approximately 49 months
Title
Percentage of Participants Who Have Treatment-emergent ADA
Description
The immunogenicity of patritumab deruxtecan will be confirmed by assessing the anti-drug antibodies.
Time Frame
Baseline up to approximately 49 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation. Has documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter. 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 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. 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). Has documentation of radiographic disease progression while receiving or after receiving a third generation EGFR TKI for metastatic or locally advanced disease. Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment. Is willing to have a tumor biopsy or provide recently obtained tumor tissue. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. 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 Exclusion Criteria: 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 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 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 Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization Has any history of or evidence of current leptomeningeal disease 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 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 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 Has uncontrolled or significant cardiovascular disease prior to randomization Has active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of randomization Has a known human immunodeficiency virus (HIV) infection that is not well controlled Has clinically significant corneal disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Contact for Clinical Trial Information
Phone
908-992-6400
Email
CTRinfo@dsi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Clinical Scientist
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Highlands Oncology
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Moores Cancer Center at the UC San Diego Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Scripps MD Anderson Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kaiser Permanente - Vallejo Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sarah Cannon/Florida Cancer Specialists - FCS South
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
St Luke's Cancer Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
American Oncology Partners of Maryland
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hackensack Meridian Health-Southern Ocean Medical Center
City
Manahawkin
State/Province
New Jersey
ZIP/Postal Code
08050
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-5303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Chris O'Brien Lifehouse
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
St George Public Hospital
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Austin Hospital
City
Melbourne
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
St John of God Subiaco Hospital
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Klinikum Klagenfurt Pulmologie
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
City
Wien
ZIP/Postal Code
1210
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
AZ Sint Maarten Mechelen
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
William Osler Health System - Brampton Civic Hospital
City
Brampton
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sunnybrook Health Sciences Ctr
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Peking University Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Jilin Cancer Hospital
City
Chang chun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hunan Cancer Hospital
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cancer Center Hospital East
City
Chibi
ZIP/Postal Code
260-0013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fujian Medical University - Union Hospital Foochow Christian Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliated Hospital Sun-Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Pecking University Third Hospital
City
Haidian
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliated Hospital of College of Medicine Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Zhejiang Cancer hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Harbin Medical University - Tumor Hospital The Third Affiliated Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology
City
Hefei
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Henan Provincial Peoples Hospital
City
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
ZIP/Postal Code
650033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Lin Yi Cancer Hospital
City
Linyi
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
General Hospital of Eastern Theater Command
City
Nanjing
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fudan University - Shanghai Cancer Center FUSCC
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
ZIP/Postal Code
515041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Withdrawn
Facility Name
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The First Affiliate Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Affiliated Cancer Hospital of Xinjiang Medical University
City
Ürümqi
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hopital Morvan CHU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076 CEDEX 05
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Montpellier Cancer Institute ICM
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Institut Curie
City
Paris Cedex 05
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
APHP - Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Institut de Cancrologie de lOuest ICO
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IKF Krankenhaus Nordwest
City
Frankfurt am main
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Asklepios Fachklinik Muenchen-Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Universitatsklinik Giessen und Marburg
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
LungenClinic Grosshansdorf
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
LKI Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Klinikverbund Allgaeu
City
Kempten
ZIP/Postal Code
87439
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Klinikum Nuernberg Nord
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Pius-Hospital Oldenburg
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Universitaetsklinikum Wurzburg
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
ZIP/Postal Code
00852
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University of Hong Kong/Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IRCCS Istituto Oncologico Giovanni Paolo II
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University G. D'Annunzio Chieti
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Ospedale San Luca
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IRCCS Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Asst Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Ospedale Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IFO Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IRCCS Humanitas Research Hospital
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
ASST Sette Laghi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hyogo Cancer Center
City
Akashi
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kansai Medical University Hospital
City
Hirakata
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Iwakuni Clinical Center
City
Iwakuni
ZIP/Postal Code
740-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Izumi City General Hospital
City
Izumi
ZIP/Postal Code
594-0073
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-Ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861- 4193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kurashiki Central Hospital
City
Kurashiki
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Matsusaka Municipal Hospital
City
Matsusaka
ZIP/Postal Code
515-8544
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
NHO Shikoku Cancer Center
City
Matsuyama
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sendai Kousei Hospital
City
Sendai
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8509
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kindai University Hospital
City
Ōsaka-sayama
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cancer Center
City
Goyang
ZIP/Postal Code
10323
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Catholic University of Korea, Seoul St. Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
St. Jansdal Ziekenhuis
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Akershus University Hospital
City
Nordbyhagen
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Oslo University Hospital-The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
8100
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
II Klinika Chorob Pluc i Gruzlicy
City
Białystok
ZIP/Postal Code
15-450
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Onko-Centrum Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-250
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Med Polonia Sp. z o.o.
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro Clinico Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Instituto Portugues de Oncologio de Lisboa
City
Lisbon
ZIP/Postal Code
1908-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centro Hospitalar de Vila Nova de Gaia - Espinho
City
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National University Cancer Institute National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cancer Centre Singapore NCCS
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
ICON Cancer Centre
City
Singapore
ZIP/Postal Code
329563
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Teresa Herrera C.H.U.A.C.
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Regional Universitario Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Univeritario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Kantonsspital Graubuenden - Hauptstandort
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kantonsspital Winterthur KSW
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
E-Da Hospital
City
Kaohsiung City
ZIP/Postal Code
824
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cheng Kung University Hospital NCKUH
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Taiwan University Hospital NTUH
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Chang Gung Memorial Hospital-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Hospital Birmingham NHS Trust
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Leeds Cancer Centre
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Hospitals of Leicester
City
Leicester
ZIP/Postal Code
LE15WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Royal Marsden Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

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