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)

Status: Active_not_recruiting
Location: See all (182) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Alaska Oncology and Hematology LLC
Anchorage
Arkansas
Highlands Oncology
Springdale
California
City of Hope
Duarte
Moores Cancer Center at the UC San Diego Health
La Jolla
Scripps MD Anderson Cancer Center
La Jolla
USC Norris Comprehensive Cancer Center
Los Angeles
Kaiser Permanente - Vallejo Medical Center
Vallejo
Innovative Clinical Research Institute
Whittier
Florida
Sarah Cannon/Florida Cancer Specialists - FCS South
Port Charlotte
Georgia
Emory University
Atlanta
Idaho
St Luke's Cancer Institute
Boise
Massachusetts
Dana-Farber Cancer Institute
Boston
Maryland
American Oncology Partners of Maryland
Bethesda
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin
New York
Memorial Sloan Kettering Cancer Center
New York
Montefiore Medical Center
The Bronx
Oregon
Providence Portland Medical Center
Portland
Tennessee
Sarah Cannon Research Institute
Nashville
Texas
University of Texas Southwestern Medical Center
Dallas
Virginia
Inova Schar Cancer Institute
Fairfax
Virginia Cancer Specialists
Fairfax
Wisconsin
University of Wisconsin Carbone Cancer Center
Madison
Other Locations
Australia
The Chris O'Brien Lifehouse
Camperdown
St George Public Hospital
Kogarah
Liverpool Hospital
Liverpool
Austin Hospital
Melbourne
St John of God Subiaco Hospital
Subiaco
Princess Alexandra Hospital
Woolloongabba
Austria
Landeskrankenhaus Feldkirch
Feldkirch
Medizinische Universitaet Innsbruck
Innsbruck
Klinikum Klagenfurt Pulmologie
Klagenfurt
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Vienna
Klinikum Wels-Grieskirchen
Wels
Belgium
Cliniques Universitaires Saint-Luc
Brussels
UZ Leuven
Leuven
AZ Sint Maarten Mechelen
Mechelen
AZ Delta
Roeselare
Canada
William Osler Health System - Brampton Civic Hospital
Brampton
China
Peking University Cancer Hospital
Beijing
Jilin Cancer Hospital
Changchun
Hunan Cancer Hospital
Changsha
University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital
Chengdu
National Cancer Center Hospital East
Chibi
Fujian Medical University - Union Hospital Foochow Christian Union Hospital
Fuzhou
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital
Guangzhou
The First Affiliated Hospital Sun-Yat-Sen University
Guangzhou
Pecking University Third Hospital
Haidian
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou
Zhejiang Cancer hospital
Hangzhou
Harbin Medical University - Tumor Hospital The Third Affiliated Hospital
Harbin
The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology
Hefei
Henan Provincial Peoples Hospital
Henan
The Second Affiliated Hospital of Kunming Medical University
Kunming
Lin Yi Cancer Hospital
Linyi
General Hospital of Eastern Theater Command
Nanjing
The First Affiliated Hospital of Guangxi Medical University
Nanning
Fudan University - Shanghai Cancer Center FUSCC
Shanghai
Cancer Hospital of Shantou University Medical College
Shantou
The First Hospital of China Medical University
Shenyang
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
Wuhan
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan
The First Affiliate Hospital of Xi'an Jiaotong University
Xi'an
Henan Cancer Hospital
Zhengzhou
France
Hopital Morvan CHU de Brest
Brest
Centre Francois Baclesse
Caen
Centre Francois Baclesse
Caen
Centre Leon Berard
Lyon
Montpellier Cancer Institute ICM
Montpellier
APHP - Hopital Saint Louis
Paris
Institut Curie
Paris
Centre Hospitalier Lyon Sud
Pierre-bénite
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes
Institut de Cancrologie de lOuest ICO
Saint-herblain
Gustave Roussy
Villejuif
Germany
Universitaetsklinikum Essen
Essen
Klinikum Esslingen GmbH
Esslingen Am Neckar
IKF Krankenhaus Nordwest
Frankfurt Am Main
Asklepios Fachklinik Muenchen-Gauting
Gauting
Universitatsklinik Giessen und Marburg
Giessen
LungenClinic Grosshansdorf
Großhansdorf
Thoraxklinik Heidelberg gGmbH
Heidelberg
LKI Lungenfachklinik Immenhausen
Immenhausen
Klinikverbund Allgaeu
Kempten
Pius-Hospital Oldenburg
Oldenburg
Hong Kong Special Administrative Region
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
University of Hong Kong/Queen Mary Hospital
Hong Kong
Italy
IRCCS Istituto Oncologico Giovanni Paolo II
Bari
University G. D'Annunzio Chieti
Chieti
Ospedale San Luca
Lucca
Asst Grande Ospedale Metropolitano Niguarda
Milan
IRCCS Istituto Europeo di Oncologia
Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano
Azienda Ospedaliero Universitaria di Parma
Parma
Ospedale Santa Maria della Misericordia
Perugia
IFO Regina Elena
Roma
IRCCS Humanitas Research Hospital
Rozzano
ASST Sette Laghi
Varese
Japan
Hyogo Cancer Center
Akashi
Kyushu University Hospital
Fukuoka
Saitama Medical University International Medical Center
Hidaka
Kansai Medical University Hospital
Hirakata
Iwakuni Clinical Center
Iwakuni
Izumi City General Hospital
Izumi
Kanazawa University Hospital
Kanazawa
The Cancer Institute Hospital of JFCR
Kōtoku
Saiseikai Kumamoto Hospital
Kumamoto
Kurashiki Central Hospital
Kurashiki
Kurume University Hospital
Kurume
Matsusaka Municipal Hospital
Matsusaka
NHO Shikoku Cancer Center
Matsuyama
National Hospital Organization Nagoya Medical Center
Nagoya
Niigata Cancer Center Hospital
Niigata
Okayama University Hospital
Okayama
Kindai University Hospital
Ōsaka-sayama
National Hospital Organization Hokkaido Cancer Center
Sapporo
Sendai Kousei Hospital
Sendai
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo
Fujita Health University Hospital
Toyoake
Wakayama Medical University Hospital
Wakayama
Netherlands
Netherlands Cancer Institute
Amsterdam
Rijnstate Ziekenhuis
Arnhem
St. Jansdal Ziekenhuis
Harderwijk
Leiden University Medical Center
Leiden
Erasmus MC
Rotterdam
University Medical Center Utrecht
Utrecht
Norway
Akershus University Hospital
Nordbyhagen
Oslo University Hospital-The Norwegian Radium Hospital
Oslo
Stavanger University Hospital
Stavanger
Poland
II Klinika Chorob Pluc i Gruzlicy
Bialystok
Onko-Centrum Sp. z o.o.
Lublin
Med Polonia Sp. z o.o.
Poznan
Portugal
Centro Clinico Champalimaud
Lisbon
Instituto Portugues de Oncologio de Lisboa
Lisbon
Centro Hospitalar de Vila Nova de Gaia - Espinho
Porto
Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio
Porto
Republic of Korea
Chungbuk National University Hospital
Cheongju-si
National Cancer Center
Goyang
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul
Singapore
ICON Cancer Centre
Singapore
National Cancer Centre Singapore NCCS
Singapore
National University Cancer Institute National University Hospital
Singapore
Tan Tock Seng Hospital
Singapore
Spain
Hospital Teresa Herrera C.H.U.A.C.
A Coruña
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
Las Palmas De Gran Canaria
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
MD Anderson Cancer Center
Madrid
Hospital Regional Universitario Malaga
Málaga
Hospital Univeritario Marques de Valdecilla
Santander
Hospital Universitario Virgen Macarena
Seville
Hospital Universitario Virgen Macarena
Seville
Switzerland
Kantonsspital Graubuenden - Hauptstandort
Chur
Kantonsspital Winterthur KSW
Winterthur
Taiwan
E-Da Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital NCKUH
Tainan City
National Taiwan University Hospital NTUH
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan District
United Kingdom
University Hospital Birmingham NHS Trust
Birmingham
Beatson West of Scotland Cancer Centre
Glasgow
Leeds Cancer Centre
Leeds
University Hospitals of Leicester
Leicester
Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre
London
The Royal Marsden Hospital NHS Foundation Trust
London
The Royal Marsden NHS Foundation Trust
London
The Christie Hospital
Manchester
The Royal Wolverhampton NHS Trust
Wolverhampton
Time Frame
Start Date: 2022-07-08
Completion Date: 2026-06-30
Participants
Target number of participants: 586
Treatments
Experimental: Patritumab deruxtecan
Participants who will be randomized to receive patritumab deruxtecan (HER3-DXd) 5.6 mg/kg q3W.
Active_comparator: Platinum-based chemotherapy
Participants who will be randomized to receive platinum-based chemotherapy for 4 cycles: pemetrexed plus either cisplatin or carboplatin. Participants without disease progression after 4 cycles of platinum plus pemetrexed therapy may continue treatment with maintenance pemetrexed with no restriction on the number of cycles.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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