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AzTrials

Non-Small Cell Lung Cancer MetastaticPhase 2NCT04619004

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

A Phase 2 study testing Patritumab Deruxtecan (Fixed dose) and Patritumab Deruxtecan (Up-Titration) in people with Non-Small Cell Lung Cancer Metastatic and Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, run by Daiichi Sankyo at 123 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patritumab Deruxtecan (Fixed dose) and Patritumab Deruxtecan (Up-Titration)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
123 sitesin 16 countries
Study dates
2 Feb 2021to 4 Jan 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants must meet all of the following criteria to be eligible for inclusion in this study.
  • Sign and date the tissue informed consent form (ICF) and the main ICF, prior to the start of any study-specific qualification procedures.
  • Male or female participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
  • Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation.
  • Documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Participants must have received both of the following:
  • Prior treatment with osimertinib. Participants receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1. Participants in South Korea known to harbor a clinically actionable genomic alteration in addition to EGFR mutation (e.g., anaplastic lymphoma kinase [ALK] or ROS1 protocol oncogene 1 [ROS1] fusion) for which treatment is available must have also received prior treatment with at least 1 approved genotype-directed therapy, unless unable (i.e., if contraindicated). No new testing for these genomic alterations (e.g., ALK or ROS1 fusion) is required for Screening.
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  • Systemic therapy with at least 1 platinum-based chemotherapy regimen.
  • Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.
  • At least 1 measurable lesion confirmed by BICR as per RECIST v1.1
  • Consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content. Required tumor tissue can be provided as either:
  • Pretreatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy OR
  • Archival tumor tissue collected from a biopsy performed within 3 months prior to signing of the tissue consent and since progression while on or after treatment with the most recent cancer therapy regimen.
  • Eastern Cooperative Oncology Group Performance Standard of 0 or 1 at Screening.
  • Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to Cycle 1 Day 1:
  • Platelet count : ≥100,000/mm^3 or ≥100 × 10^9/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility)
  • Hemoglobin: ≥9.0 g/dL (transfusion and/or growth factor support is allowed)
  • Absolute neutrophil count: ≥1500/mm^3 or ≥1.5 × 10^9/L
  • Serum creatinine (SCr) or creatinine clearance (CrCl): SCr ≤1.5 × upper limit of normal (ULN), OR CrCl ≥30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl
  • Aspartate aminotransferase/alanine aminotransferase: ≤3 × ULN (if liver metastases are present, ≤5 × ULN)
  • Total bilirubin: ≤1.5 × ULN if no liver metastases (<3 × ULN in the presence of documented Gilbert's syndrome [unconjugated hyperbilirubinemia] or liver metastases)
  • Serum albumin: ≥2.5 g/dL
  • Prothrombin time (PT) or PT-International normalized ratio (INR) and activated partial thromboplastin time (aPTT)/PTT: ≤1.5 × ULN, except for subjects on 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

  • Participants meeting any exclusion criteria for this study will be excluded from this study.
  • 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.
  • Any history of interstitial lung disease (including pulmonary fibrosis or radiation pneumonitis), has current interstitial lung disease (ILD), or is suspected to have such disease by imaging during screening.
  • Clinically severe respiratory compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
  • Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months prior to the study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD]), restrictive lung disease, pleural effusion);
  • Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); OR prior complete pneumonectomy.
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  • Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory or any form of immunosuppressive therapy prior to enrollment. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
  • Evidence of any leptomeningeal disease.
  • Evidence of clinically active spinal cord compression or brain metastases.
  • Inadequate washout period prior to Cycle 1 Day 1, defined as:
  • Whole brain radiation therapy <14 days or stereotactic brain radiation therapy <7 days;
  • Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), <14 days or 5 half-lives, whichever is longer;
  • Monoclonal antibodies, other than immune checkpoint inhibitors, such as bevacizumab (anti-VEGF) and cetuximab (anti-EGFR) <28 days;
  • Immune checkpoint inhibitor therapy <21 days;
  • Major surgery (excluding placement of vascular access) <28 days;
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 days; or
  • Chloroquine or hydroxychloroquine <14 days.
  • Prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody or single-agent topoisomerase I inhibitor.
  • Prior treatment with an antibody drug conjugate (ADC) that consists of any topoisomerase I inhibitor
  • Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade ≤1 or baseline. Participants with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee.
  • Has history of other active malignancy within 3 years prior to enrollment, except:
  • Adequately treated non-melanoma skin cancer;
  • Superficial bladder tumors (Ta, Tis, T1);
  • Adequately treated intraepithelial carcinoma of the cervix uteri;
  • Low risk non-metastatic prostate cancer (with Gleason score <7, and following local treatment or ongoing active surveillance);
  • Any other curatively treated in situ disease.
  • Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1
  • Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1.
  • Participant with any human immunodeficiency virus (HIV) infection.

Trial locations and contacts

123 sites in 16 countries.

123 sites in 16 countries

United States33 sites

  • University of Colorado Denver - Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Maryland - Marlene and Stewart Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital (MGH) - Hematology/Oncology

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center, Harvard Medical School

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia Cancer Center - Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22903

  • Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195

  • Henry Ford Cancer Institute/Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • Emory University

    Dunwoody, Georgia, 30338

  • Virginia Cancer Specialist, PC

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33901

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Moores Cancer Center at the UC San Diego Health

    La Jolla, California, 92093

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Mount Sinai Hospital

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California at Irvine

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33021

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • University of Washington/Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Florida Cancer Specialist-North

    St. Petersburg, Florida, 33770

  • Florida Cancer Specialists-Panhandle

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Cedars Sinai

    West Hollywood, California, 90048

  • Florida Cancer Specialists-East

    West Palm Beach, Florida, 33401

Other trials in United States

Japan15 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • The Cancer Institute Hospital of JFCR

    Ariake, Koto, 135-8550

  • National Cancer Center Hospital East

    Chiba, Kashiwa-shi, 277-8577

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045

  • Niigata Cancer Center Hospital

    Chuo Ku Niigata-shi, 961-8566

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1347

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-0882

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589-8511

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

Other trials in Japan

China11 sites

  • Beijing Cancer Hospital

    Beijing, 100036

  • Jilin Cancer Hospital

    Changchun, 130012

  • University of Electronic Science & Technology of China (UESTC) - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital

    Chengdu, 610041

  • Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital of College of Medicine Zhejiang University

    Hangzhou, 310003

  • Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)

    Harbin, 150081

  • General Hospital of Eastern Theater Command

    Nanjing, 210002

  • Fudan University - Shanghai Cancer Center FUSCC

    Shanghai, 200032

  • The First Hospital of China Medical University

    Shenyang, 110001

  • Union Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain10 sites

  • Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO

    Badalona, Cataluã'a, 08916

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • START Madrid - Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Clinico Universitario Lozano Bleza

    Zaragoza, 50009

Other trials in Spain

France8 sites

  • Hopital Morvan CHU de Brest

    Brest, 29609

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38043

  • Centre Leon Berard

    Lyon, Rhone, 69008

  • University Hospital of Nantes - Thoracic Oncology

    Nantes, Loire-Atlantique, 44000

  • Institut Curie

    Paris, 75248

  • Hopital Pontchaillou

    Rennes, 35000

  • CHU Toulouse - Hopital Larrey

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

South Korea8 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital

    Seoul, 06591

  • Asan Medical Center

    Songpa-gu, Seoul, 05505

Other trials in South Korea

Taiwan8 sites

  • E-Da Hospital

    Kaohsiung City, 824

  • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

    Niaosong, 83301

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chung Shan Medical University Hospital

    Taichung, 420

  • National Cheng Kung University Hospital

    Tainan, Tai Nan Shi, 704

  • National Taiwan University Hospital NTUH

    Taipei, 100

  • MacKay Memorial Hospital

    Taipei, 10449

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Australia6 sites

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • The Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • St George Public Hospital

    Kogarah, New South Wales, 2217

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Germany6 sites

  • Universitaet zu Koeln - Uniklinik Koeln

    Cologne, North Rhine-Westphal, 50937

  • Universitaet zu Koeln - Uniklinik Koeln

    Cologne, 50931

  • Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim

    Cologne, 51109

  • University Cancer Center

    Dresden, 01307

  • LungenClinic Grosshansdorf

    Großhansdorf, Schleswig-Holstein, 22927

  • Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim

    Köln, North Rhine-Westphalia, 51109

Other trials in Germany

Italy5 sites

  • IRCCS - Istituto Scientifico Romagnolo per lo Studio e La Cura Dei Tumori ISRT

    Meldola, 47014

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Turin, 10043

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Province Of Parma, 43126

  • Humanitas Cancer Center

    Rozzano, 20089

Other trials in Italy

United Kingdom4 sites

  • University Hospital Birmingham NHS Trust

    Birmingham, B9 5SS

  • The Royal Marsden NHS Foundation Trust

    London, E20 1JQ

  • University College London Hospitals

    London, NW12PG

  • The Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

Bulgaria3 sites

  • MHAT Uni Hospital OOD

    Panagyurishte, 4500

  • Complex Oncological Center - Russe

    Rousse, 7002

  • MHAT Serdika

    Sofia, 1303

Other trials in Bulgaria

Singapore3 sites

  • National University Cancer Institute National University Hospital

    Singapore, 119074

  • National Cancer Centre Singapore NCCS

    Singapore, 169610

  • OncoCare Cancer Centre- Gleneagles Medical Centre

    Singapore, 258499

Other trials in Singapore

Austria1 site

  • Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

    Vienna, 1030

Other trials in Austria

Belgium1 site

  • Universitaire Ziekenhuis Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Netherlands1 site

  • Netherlands Cancer Institute

    Amsterdam, 1066CX

Other trials in Netherlands

About this study

Official title: HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.

Read the detailed description

This study will initially randomize participants to one of 2 arms in a 1:1 ratio to receive either a 5.6 mg/kg fixed dose regimen or an up-titration dose regimen of patritumab deruxtecan (HER3-DXd, U3-1402).

Being tested
Patritumab Deruxtecan (Fixed dose), Patritumab Deruxtecan (Up-Titration)
Keywords
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer with Mutation in Epidermal Growth Factor Receptor, Epidermal growth factor receptor, HER3-DXd, Patritumab Deruxtecan, U3-1402

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patritumab Deruxtecan (Fixed dose)Drug

    Also called U3-1402, HER3-DXd

    Patritumab deruxtecan will be dosed at 5.6 mg/kg as an intravenous (IV) infusion administered on Day 1 of each 21-day cycle.

  • Patritumab Deruxtecan (Up-Titration)Drug

    Also called U3-1402, HER3-DXd

    Patritumab deruxtecan will be dosed as an intravenous (IV) infusion administered at Cycle 1, 3.2 mg/kg; Cycle 2, 4.8 mg/kg; Cycle 3 and subsequent cycles, 6.4 mg/kg administered on Day 1 of each 21-day cycle.

Study groups in NCT04619004
Study groupRoleWhat they receive
Study Group 1: Patritumab deruxtecan 5.6 mg/kgExperimentalStudy Group 1 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)
Receives: Drug: Patritumab Deruxtecan (Fixed dose)
Study Group 2: Patritumab deruxtecan Up-TitrationExperimentalStudy Group 2 will be participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation randomized to receive patritumab deruxtecan up-titration IV every 3 weeks (Q3W)
Receives: Drug: Patritumab Deruxtecan (Up-Titration)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)

    ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.

    Measured: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Secondary outcomes (8)

  1. Duration of Response (DoR)

    DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

  2. Progression-free Survival (PFS)

    PFS is defined as the time from the start of study treatment to the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by BICR and by Investigator, respectively.

    Measured: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

  3. Objective Response Rate (ORR) as Assessed by the Investigator

    ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR as assessed by the Investigator per RECIST v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

  4. Disease Control Rate (DCR)

    DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

    Measured: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

  5. Time to Tumor Response (TTR)

    TTR is defined as the time from the start of study treatment to the date of the first documentation of confirmed response (CR or PR) as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

  6. Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors

    The best percentage change in the SoD of measurable tumors is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.

    Measured: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

  7. Overall Survival (OS)

    OS defined as the time from the start of study treatment to the date of death due to any cause.

    Measured: Death date is collected until the participant discontinues the study or up to approximately 45 months

  8. Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)

    A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. Adverse events will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.

    Measured: From baseline up to Day 47 post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start2 Feb 2021
  3. Primary completion21 Nov 2022
  4. Study completion4 Jan 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619004
Sponsor's protocol ID
U31402-A-U201
Other IDs
2020-000730-17, 2024-512238-13-00
Status last verified
Oct 2026
First submitted
29 Oct 2020
Last updated
2 Nov 2026
Data monitoring committee
No
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

  • Yu HA, Goto Y, Janne PA. A study to learn how well HER3-DXd (patritumab deruxtecan) works and how safe it is in people with previously treated non-small-cell lung cancer that has a mutation in the EGFR gene: a plain language summary of the HERTHENA-Lung01 study. Future Oncol. 2026 Oct 12:1-16. doi: 10.1080/14796694.2026.2691681. Online ahead of print.

    PubMed 42860885

  • Patel J, Meng J, Le H, Tanaka Y, Phani S, Salas M, Wu C, Sternberg D, Esker S, Anderson JP, Crowley A, Zhou SQ, Lieb C, Sun H, Doan QV, Santhanagopal A, Reckamp KL. Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic or Unresectable EGFR-Mutated Non-Small Cell Lung Cancer Previously Treated with Osimertinib and Platinum-Based Chemotherapy. Adv Ther. 2024 Aug;41(8):3299-3315. doi: 10.1007/s12325-024-02936-4. Epub 2024 Jul 3.

    PubMed 38958845

  • 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.

    PubMed 37689979

  • Yu HA, Yang JC, Hayashi H, Goto Y, Felip E, Reck M, Vigliotti M, Dong Q, Cantero F, Fan PD, Kanai M, Sternberg DW, Janne PA. HERTHENA-Lung01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated metastatic EGFR-mutated NSCLC. Future Oncol. 2023 Jun;19(19):1319-1329. doi: 10.2217/fon-2022-1250. Epub 2023 May 22.

    PubMed 37212796

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patritumab Deruxtecan (Fixed dose) and Patritumab Deruxtecan (Up-Titration) in people with Non-Small Cell Lung Cancer Metastatic and Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, run by Daiichi Sankyo at 123 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Japan, China, Spain, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) (time frame: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04619004, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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