Nonsquamous Non-small Cell Lung CancerPhase 3NCT05338970
HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
A Phase 3 study testing Patritumab Deruxtecan and Platinum-based chemotherapy in people with Nonsquamous Non-small Cell Lung Cancer and EGFR L858R, run by Daiichi Sankyo at 182 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion
- What is being tested?
- Patritumab Deruxtecan and Platinum-based chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 182 sitesin 21 countries
- Study dates
- 8 Jul 2022to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
182 sites in 21 countries.
182 sites in 21 countries
China26 sites
Peking University Cancer Hospital
Beijing, 100142
Jilin Cancer Hospital
Changchun, 130021
Hunan Cancer Hospital
Changsha, 410013
University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital
Chengdu, 610041
National Cancer Center Hospital East
Chibi, 260-0013
Fujian Medical University - Union Hospital Foochow Christian Union Hospital
Fuzhou, 350001
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital
Guangzhou, 510080
The First Affiliated Hospital Sun-Yat-Sen University
Guangzhou, 510080
Pecking University Third Hospital
Haidian, 100191
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, 310003
Zhejiang Cancer hospital
Hangzhou, 310022
Harbin Medical University - Tumor Hospital The Third Affiliated Hospital
Harbin, 150081
The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology
Hefei, 230022
Henan Provincial Peoples Hospital
Henan, 450003
The Second Affiliated Hospital of Kunming Medical University
Kunming, 650033
Lin Yi Cancer Hospital
Linyi, 276000
General Hospital of Eastern Theater Command
Nanjing, 210002
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021
Fudan University - Shanghai Cancer Center FUSCC
Shanghai, 200032
Cancer Hospital of Shantou University Medical College
Shantou, 515041
The First Hospital of China Medical University
Shenyang, 110001
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, 830000
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
Wuhan, 430030
The First Affiliate Hospital of Xi'an Jiaotong University
Xi'an, 710061
Henan Cancer Hospital
Zhengzhou, 450008
United States23 sites
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Emory University
Atlanta, Georgia, 30322
American Oncology Partners of Maryland
Bethesda, Maryland, 20817
St Luke's Cancer Institute
Boise, Idaho, 83712
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
City of Hope
Duarte, California, 91010
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Moores Cancer Center at the UC San Diego Health
La Jolla, California, 92037
Scripps MD Anderson Cancer Center
La Jolla, California, 92037
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin, New Jersey, 08050
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sarah Cannon/Florida Cancer Specialists - FCS South
Port Charlotte, Florida, 33980
Providence Portland Medical Center
Portland, Oregon, 97213
Highlands Oncology
Springdale, Arkansas, 72762
Montefiore Medical Center
The Bronx, New York, 10467
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, 94589
Innovative Clinical Research Institute
Whittier, California, 90603
Japan22 sites
Hyogo Cancer Center
Akashi, 673-8558
Kyushu University Hospital
Fukuoka, 812-8582
Saitama Medical University International Medical Center
Hidaka, 350-1298
Kansai Medical University Hospital
Hirakata, 573-1191
Iwakuni Clinical Center
Iwakuni, 740-8510
Izumi City General Hospital
Izumi, 594-0073
Kanazawa University Hospital
Kanazawa, 920-8641
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
Saiseikai Kumamoto Hospital
Kumamoto, 861- 4193
Kurashiki Central Hospital
Kurashiki, 710-8602
Kurume University Hospital
Kurume, 830-0011
Matsusaka Municipal Hospital
Matsusaka, 515-8544
NHO Shikoku Cancer Center
Matsuyama, 791-0280
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
Niigata Cancer Center Hospital
Niigata, 951-8566
Okayama University Hospital
Okayama, 700-8558
Kindai University Hospital
Ōsaka-sayama, 589-8511
National Hospital Organization Hokkaido Cancer Center
Sapporo, 003-0804
Sendai Kousei Hospital
Sendai, 980-0873
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, 113-8677
Fujita Health University Hospital
Toyoake, 470-1192
Wakayama Medical University Hospital
Wakayama, 641-8509
Spain13 sites
Hospital Teresa Herrera C.H.U.A.C.
A Coruña, 15006
Hospital del Mar
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016
Hospital General Universitario Gregorio Maranon
Madrid, 28007
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario Malaga
Málaga, 29010
Hospital Univeritario Marques de Valdecilla
Santander, 39120
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen Macarena
Seville, 41071
France11 sites
Hopital Morvan CHU de Brest
Brest, 29609
Centre Francois Baclesse
Caen, 14076 CEDEX 05
Centre Francois Baclesse
Caen, 14076
Centre Leon Berard
Lyon, 69008
Montpellier Cancer Institute ICM
Montpellier, 34298
Institut Curie
Paris, 75005
APHP - Hopital Saint Louis
Paris, 75010
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes, 35000
Institut de Cancrologie de lOuest ICO
Saint-Herblain, 44805
Gustave Roussy
Villejuif, 94805
Italy11 sites
IRCCS Istituto Oncologico Giovanni Paolo II
Bari, 70124
University G. D'Annunzio Chieti
Chieti, 66100
Ospedale San Luca
Lucca, 55100
IRCCS Istituto Europeo di Oncologia
Milan, 20141
Asst Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, 10043
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Ospedale Santa Maria della Misericordia
Perugia, 06132
IFO Regina Elena
Roma, 00144
IRCCS Humanitas Research Hospital
Rozzano, 20089
ASST Sette Laghi
Varese, 21100
Germany10 sites
Universitaetsklinikum Essen
Essen, 45147
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
IKF Krankenhaus Nordwest
Frankfurt am Main, 60488
Asklepios Fachklinik Muenchen-Gauting
Gauting, 82131
Universitatsklinik Giessen und Marburg
Giessen, 35392
LungenClinic Grosshansdorf
Großhansdorf, 22927
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126
LKI Lungenfachklinik Immenhausen
Immenhausen, 34376
Klinikverbund Allgaeu
Kempten, 87439
Pius-Hospital Oldenburg
Oldenburg, 26121
South Korea9 sites
Chungbuk National University Hospital
Cheongju-si, 28644
National Cancer Center
Goyang, 10323
Seoul National University Bundang Hospital
Seongnam, 463-707
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, 06591
Samsung Medical Center
Seoul, 135-710
United Kingdom9 sites
University Hospital Birmingham NHS Trust
Birmingham, B9 5SS
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Leeds Cancer Centre
Leeds, LS9 7TF
University Hospitals of Leicester
Leicester, LE15WW
Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre
London, EC1A 7BE
The Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Christie Hospital
Manchester, M20 4BX
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
Australia6 sites
The Chris O'Brien Lifehouse
Camperdown, 2050
St George Public Hospital
Kogarah, 2217
Liverpool Hospital
Liverpool, 2170
Austin Hospital
Melbourne, 3084
St John of God Subiaco Hospital
Subiaco, 6008
Princess Alexandra Hospital
Woolloongabba, 4102
Netherlands6 sites
Netherlands Cancer Institute
Amsterdam, 1066 CX
Rijnstate Ziekenhuis
Arnhem, 6815 AD
St. Jansdal Ziekenhuis
Harderwijk, 3844 DG
Leiden University Medical Center
Leiden, 2333ZA
Erasmus MC
Rotterdam, 3015 CD
University Medical Center Utrecht
Utrecht, 3584 CX
Taiwan6 sites
E-Da Hospital
Kaohsiung City, 824
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital NCKUH
Tainan, 704
National Taiwan University Hospital NTUH
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan, 333
Austria5 sites
Landeskrankenhaus Feldkirch
Feldkirch, 6800
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Klinikum Klagenfurt Pulmologie
Klagenfurt, 9020
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Vienna, 1210
Klinikum Wels-Grieskirchen
Wels, 4600
Belgium4 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
AZ Sint Maarten Mechelen
Mechelen, 2800
AZ Delta
Roeselare, 8800
Hong Kong4 sites
Pamela Youde Nethersole Eastern Hospital
Hong Kong, 00852
Prince of Wales Hospital
Hong Kong, 999077
University of Hong Kong/Queen Mary Hospital
Hong Kong, 999077
Queen Elizabeth Hospital
Hong Kong
Portugal4 sites
Centro Clinico Champalimaud
Lisbon, 1400-038
Instituto Portugues de Oncologio de Lisboa
Lisbon, 1908-072
Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio
Porto, 4099-001
Centro Hospitalar de Vila Nova de Gaia - Espinho
Porto, 4434-502
Singapore4 sites
National University Cancer Institute National University Hospital
Singapore, 119074
National Cancer Centre Singapore NCCS
Singapore, 169610
Tan Tock Seng Hospital
Singapore, 308433
ICON Cancer Centre
Singapore, 329563
Norway3 sites
Akershus University Hospital
Lørenskog, 1478
Oslo University Hospital-The Norwegian Radium Hospital
Oslo, 0379
Stavanger University Hospital
Stavanger, 8100
Poland3 sites
II Klinika Chorob Pluc i Gruzlicy
Bialystok, 15-450
Onko-Centrum Sp. z o.o.
Lublin, 20-250
Med Polonia Sp. z o.o.
Poznan, 60-693
Switzerland2 sites
Kantonsspital Graubuenden - Hauptstandort
Chur, 7000
Kantonsspital Winterthur KSW
Winterthur, 8400
Canada1 site
William Osler Health System - Brampton Civic Hospital
Brampton, L6R 3J7
About this study
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)
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 suggests that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.
Read the 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.
- Being tested
- Patritumab Deruxtecan, Platinum-based chemotherapy
- Keywords
- Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR exon 19 deletion, Patritumab deruxtecan, HER3-DXd, U3-1402
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patritumab DeruxtecanDrug
Also called HER3-DXd, U3-1402
Intravenous administration, 5.6 mg/kg every 3 weeks (q3W).
Platinum-based chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patritumab deruxtecan | Experimental | Participants received patritumab deruxtecan (HER3-DXd) 5.6 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 of each 21-day cycle (every 3 weeks [q3W]) until occurrence of unacceptable toxicity, radiographic or clinical disease progression (PD), withdrawal of consent, physician decision, pregnancy, loss to follow-up or death, whichever occurs first; data cut-off (DCO) date: 31 May 2024. Receives: Drug: Patritumab Deruxtecan |
| Platinum-based chemotherapy | Active comparator | Participants received platinum-based chemotherapy; pemetrexed (500 milligrams per square meter [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), IV on Day 1 of each cycle up to 4 cycles or until PD, whichever occurs first. Participants without disease progression after 4 cycles of platinum plus pemetrexed therapy continued treatment with maintenance pemetrexed with no restriction on the number of cycles; data cut-off (DCO) date: 31 May 2024. Receives: Drug: Platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to approximately 49 months
Secondary outcomes (18)
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.
Measured: Baseline up to approximately 32 months
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.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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).
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
Intracranial PFS as Assessed by BICR
Intracranial PFS is defined as the time from the date of randomization to the earlier of the dates of the first documented radiographic intracranial disease progression or death, whichever comes first, as assessed by BICR per CNS-RECIST, in participants with CNS lesion(s) at baseline by BICR per CNS-RECIST.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
Mean Change from Baseline in Patient's Global Impression of Severity
The PGI-S is a one-item questionnaire that contains six response options.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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).
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
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.
Measured: Baseline up to approximately 49 months
Percentage of Participants Who Have Treatment-emergent ADA
The immunogenicity of patritumab deruxtecan will be confirmed by assessing the anti-drug antibodies.
Measured: Baseline up to approximately 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start8 Jul 2022
- Primary completion31 May 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonsquamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Physician Scientist, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338970
- Sponsor's protocol ID
- U31402-A-U301
- Other IDs
- 2021-005879-40, jRCT 2021220002, 2023-507964-38-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Publications
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.
PubMed 38095056Yu 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.
PubMed 37689979