HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
NCT ID: NCT05338970
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
586 participants
INTERVENTIONAL
2022-07-08
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patritumab deruxtecan
Participants who will be randomized to receive patritumab deruxtecan (HER3-DXd) 5.6 mg/kg q3W.
Patritumab Deruxtecan
Intravenous administration, 5.6 mg/kg every 3 weeks (q3W)
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.
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
Interventions
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Patritumab Deruxtecan
Intravenous administration, 5.6 mg/kg every 3 weeks (q3W)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Clinical Scientist
Role: STUDY_CHAIR
Daiichi Sankyo
Locations
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Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Highlands Oncology
Springdale, Arkansas, United States
City of Hope
Duarte, California, United States
Moores Cancer Center at the UC San Diego Health
La Jolla, California, United States
Scripps MD Anderson Cancer Center
La Jolla, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Sarah Cannon/Florida Cancer Specialists - FCS South
Port Charlotte, Florida, United States
Emory University
Atlanta, Georgia, United States
St Luke's Cancer Institute
Boise, Idaho, United States
American Oncology Partners of Maryland
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
The Chris O'Brien Lifehouse
Camperdown, , Australia
St George Public Hospital
Kogarah, , Australia
Liverpool Hospital
Liverpool, , Australia
Austin Hospital
Melbourne, , Australia
St John of God Subiaco Hospital
Subiaco, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Landeskrankenhaus Feldkirch
Feldkirch, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Klinikum Klagenfurt Pulmologie
Klagenfurt, , Austria
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Vienna, , Austria
Klinikum Wels-Grieskirchen
Wels, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Sint Maarten Mechelen
Mechelen, , Belgium
AZ Delta
Roeselare, , Belgium
William Osler Health System - Brampton Civic Hospital
Brampton, , Canada
Peking University Cancer Hospital
Beijing, , China
Jilin Cancer Hospital
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital
Chengdu, , China
National Cancer Center Hospital East
Chibi, , China
Fujian Medical University - Union Hospital Foochow Christian Union Hospital
Fuzhou, , China
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital
Guangzhou, , China
The First Affiliated Hospital Sun-Yat-Sen University
Guangzhou, , China
Pecking University Third Hospital
Haidian, , China
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, , China
Zhejiang Cancer hospital
Hangzhou, , China
Harbin Medical University - Tumor Hospital The Third Affiliated Hospital
Harbin, , China
The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology
Hefei, , China
Henan Provincial Peoples Hospital
Henan, , China
The Second Affiliated Hospital of Kunming Medical University
Kunming, , China
Lin Yi Cancer Hospital
Linyi, , China
General Hospital of Eastern Theater Command
Nanjing, , China
The First Affiliated Hospital of Guangxi Medical University
Nanning, , China
Fudan University - Shanghai Cancer Center FUSCC
Shanghai, , China
Cancer Hospital of Shantou University Medical College
Shantou, , China
The First Hospital of China Medical University
Shenyang, , China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, , China
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
Wuhan, , China
The First Affiliate Hospital of Xi'an Jiaotong University
Xi'an, , China
Henan Cancer Hospital
Zhengzhou, , China
Hopital Morvan CHU de Brest
Brest, , France
Centre Francois Baclesse
Caen, , France
Centre Francois Baclesse
Caen, , France
Centre Leon Berard
Lyon, , France
Montpellier Cancer Institute ICM
Montpellier, , France
Institut Curie
Paris, , France
APHP - Hopital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes, , France
Institut de Cancrologie de lOuest ICO
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Universitaetsklinikum Essen
Essen, , Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
IKF Krankenhaus Nordwest
Frankfurt am Main, , Germany
Asklepios Fachklinik Muenchen-Gauting
Gauting, , Germany
Universitatsklinik Giessen und Marburg
Giessen, , Germany
LungenClinic Grosshansdorf
Großhansdorf, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
LKI Lungenfachklinik Immenhausen
Immenhausen, , Germany
Klinikverbund Allgaeu
Kempten, , Germany
Pius-Hospital Oldenburg
Oldenburg, , Germany
Pamela Youde Nethersole Eastern Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Hong Kong, , Hong Kong
University of Hong Kong/Queen Mary Hospital
Hong Kong, , Hong Kong
Queen Elizabeth Hospital
Hong Kong, , Hong Kong
IRCCS Istituto Oncologico Giovanni Paolo II
Bari, , Italy
University G. D'Annunzio Chieti
Chieti, , Italy
Ospedale San Luca
Lucca, , Italy
IRCCS Istituto Europeo di Oncologia
Milan, , Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Ospedale Santa Maria della Misericordia
Perugia, , Italy
IFO Regina Elena
Roma, , Italy
IRCCS Humanitas Research Hospital
Rozzano, , Italy
ASST Sette Laghi
Varese, , Italy
Hyogo Cancer Center
Akashi, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Saitama Medical University International Medical Center
Hidaka, , Japan
Kansai Medical University Hospital
Hirakata, , Japan
Iwakuni Clinical Center
Iwakuni, , Japan
Izumi City General Hospital
Izumi, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
The Cancer Institute Hospital of JFCR
Kōtoku, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, , Japan
Kurashiki Central Hospital
Kurashiki, , Japan
Kurume University Hospital
Kurume, , Japan
Matsusaka Municipal Hospital
Matsusaka, , Japan
NHO Shikoku Cancer Center
Matsuyama, , Japan
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Kindai University Hospital
Ōsaka-sayama, , Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, , Japan
Sendai Kousei Hospital
Sendai, , Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, , Japan
Fujita Health University Hospital
Toyoake, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Netherlands Cancer Institute
Amsterdam, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
St. Jansdal Ziekenhuis
Harderwijk, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Akershus University Hospital
Nordbyhagen, , Norway
Oslo University Hospital-The Norwegian Radium Hospital
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
II Klinika Chorob Pluc i Gruzlicy
Bialystok, , Poland
Onko-Centrum Sp. z o.o.
Lublin, , Poland
Med Polonia Sp. z o.o.
Poznan, , Poland
Centro Clinico Champalimaud
Lisbon, , Portugal
Instituto Portugues de Oncologio de Lisboa
Lisbon, , Portugal
Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio
Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia - Espinho
Porto, , Portugal
National University Cancer Institute National University Hospital
Singapore, , Singapore
National Cancer Centre Singapore NCCS
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
ICON Cancer Centre
Singapore, , Singapore
Chungbuk National University Hospital
Cheongju-si, , South Korea
National Cancer Center
Goyang, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Teresa Herrera C.H.U.A.C.
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario Malaga
Málaga, , Spain
Hospital Univeritario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Kantonsspital Graubuenden - Hauptstandort
Chur, , Switzerland
Kantonsspital Winterthur KSW
Winterthur, , Switzerland
E-Da Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital NCKUH
Tainan City, , Taiwan
National Taiwan University Hospital NTUH
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan District, , Taiwan
University Hospital Birmingham NHS Trust
Birmingham, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Leeds Cancer Centre
Leeds, , United Kingdom
University Hospitals of Leicester
Leicester, , United Kingdom
Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre
London, , United Kingdom
The Royal Marsden Hospital NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Countries
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References
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Mok T, Janne PA, Nishio M, Novello S, Reck M, Steuer C, Wu YL, Fougeray R, Fan PD, Meng J, Sternberg DW, Esker S, Yu HA. HERTHENA-Lung02: phase III study of patritumab deruxtecan in advanced EGFR-mutated NSCLC after a third-generation EGFR TKI. Future Oncol. 2024 May;20(15):969-980. doi: 10.2217/fon-2023-0602. Epub 2023 Dec 14.
Yu HA, Goto Y, Hayashi H, Felip E, Chih-Hsin Yang J, Reck M, Yoh K, Lee SH, Paz-Ares L, Besse B, Bironzo P, Kim DW, Johnson ML, Wu YL, John T, Kao S, Kozuki T, Massarelli E, Patel J, Smit E, Reckamp KL, Dong Q, Shrestha P, Fan PD, Patel P, Sporchia A, Sternberg DW, Sellami D, Janne PA. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy. J Clin Oncol. 2023 Dec 10;41(35):5363-5375. doi: 10.1200/JCO.23.01476. Epub 2023 Sep 10.
Other Identifiers
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2021-005879-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT 2021220002
Identifier Type: OTHER
Identifier Source: secondary_id
U31402-A-U301
Identifier Type: -
Identifier Source: org_study_id
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