Lung Cancer Clinical Trial

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

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.

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Full 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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.
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

Exclusion Criteria:

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.
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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

420

Study ID:

NCT04619004

Recruitment Status:

Recruiting

Sponsor:

Daiichi Sankyo, Inc.

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There are 116 Locations for this study

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Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
City of Hope
Duarte California, 91010, United States
Moores Cancer Center at the UC San Diego Health
La Jolla California, 92093, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
University of California at Irvine
Orange California, 92868, United States
Cedars Sinai
West Hollywood California, 90048, United States
University of Colorado Denver - Anschutz Medical Campus
Aurora Colorado, 80045, United States
Florida Cancer Specialists - South
Fort Myers Florida, 33901, United States
AdventHealth Orlando
Orlando Florida, 32804, United States
Memorial Healthcare System
Pembroke Pines Florida, 33021, United States
Florida Cancer Specialist-North
Saint Petersburg Florida, 33770, United States
Florida Cancer Specialists-Panhandle
Tallahassee Florida, 32308, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Florida Cancer Specialists-East
West Palm Beach Florida, 33401, United States
Emory University
Dunwoody Georgia, 30338, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital (MGH) - Hematology/Oncology
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston Massachusetts, 02215, United States
Henry Ford Cancer Institute/Henry Ford Hospital
Detroit Michigan, 48202, United States
Mount Sinai Hospital
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Cleveland Clinic - Main Campus
Cleveland Ohio, 44195, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga
Chattanooga Tennessee, 37404, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center
Charlottesville Virginia, 22903, United States
Virginia Cancer Specialist, PC
Fairfax Virginia, 22031, United States
University of Washington/Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Blacktown Hospital
Blacktown New South Wales, 2148, Australia
The Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
St George Public Hospital
Kogarah New South Wales, 2217, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
St John of God Subiaco Hospital
Subiaco Western Australia, 6008, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Wien , 1030, Austria
Universitaire Ziekenhuis Gasthuisberg
Leuven , 3000, Belgium
MHAT Uni Hospital OOD
Panagyurishte , 4500, Bulgaria
Complex Oncological Center - Russe
Russe , 7002, Bulgaria
MHAT Serdika
Sofia , 1303, Bulgaria
Beijing Cancer Hospital
Beijing , 10003, China More Info
Principal Investigator
Contact
Jilin Cancer Hospital
Chang chun , 13001, China More Info
Principal Investigator
Contact
University of Electronic Science & Technology of China (UESTC) - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital
Chengdu , 61004, China More Info
Principal Investigator
Contact
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital
Guangzhou , 51008, China More Info
Principal Investigator
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The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou , 31000, China More Info
Principal Investigator
Contact
Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)
Harbin , 15008, China More Info
Principal Investigator
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General Hospital of Eastern Theater Command
Nanjing , 21000, China More Info
Principal Investigator
Contact
Fudan University - Shanghai Cancer Center FUSCC
Shanghai , 20003, China More Info
Principal Investigator
Contact
The First Hospital of China Medical University
Shenyang , 11000, China More Info
Principal Investigator
Contact
Liaoning Cancer Hospital
Shenyang , 11004, China
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan , 43002, China More Info
Principal Investigator
Contact
Henan Cancer Hospital
Zhengzhou , 45000, China More Info
Principal Investigator
Contact
CHU Toulouse - Hopital Larrey
Toulouse Haute-Garonne, 31059, France
University Hospital of Nantes - Thoracic Oncology
Nantes Loire-Atlantique, 44000, France
Centre Leon Berard
Lyon Rhone, 69008, France
Hopital Morvan CHU de Brest
Brest , 29609, France
Centre Hospitalier Universitaire de Grenoble
Grenoble , 38043, France
Institut Curie
Paris , 75248, France
Hopital Pontchaillou
Rennes , 35000, France
Gustave Roussy
Villejuif , 94805, France
Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim
Köln Nordrhein-Westfalen, 51109, Germany
Universitaet zu Koeln - Uniklinik Koeln
Koeln North Rhine-Westphal, 50937, Germany
LungenClinic Grosshansdorf
Großhansdorf Schleswig-Holstein, 22927, Germany
University Cancer Center
Dresden , 01307, Germany
LungenClinic Grosshansdorf
Großhansdorf , 22927, Germany
Universitaet zu Koeln - Uniklinik Koeln
Koeln , 50931, Germany
Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim
Koeln , 51109, Germany
Azienda Ospedaliero Universitaria di Parma
Parma Province Of Parma, 43126, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano Turin, 10043, Italy
IRCCS - Istituto Scientifico Romagnolo per lo Studio e La Cura Dei Tumori ISRT
Meldola , 47014, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milano , 20133, Italy
Humanitas Cancer Center
Rozzano , 20089, Italy
National Cancer Center Hospital East
Kashiwa Chiba, 277-0, Japan
National Cancer Center Hospital
Tokyo Chuo-ku, 104-0, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo Hokkaido, 003-0, Japan
Hyogo Cancer Center
Akashi Hyogo, 673-8, Japan
National Cancer Center Hospital East
Chiba Kashiwa-shi, 277-8, Japan
The Cancer Institute Hospital of JFCR
Ariake Koto, 135-8, Japan
Sendai Kousei Hospital
Sendai Miyagi, 980-0, Japan
Kansai Medical University Hospital
Hirakata Osaka, 573-1, Japan
Kindai University Hospital
Ōsaka-sayama Osaka, 589-8, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
National Cancer Center Hospital
Chuo Ku Tokyo, 104-0, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo , 003-0, Japan
Asan Medical Center
Songpa-gu Seoul, 05505, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul , 06591, Korea, Republic of
Netherlands Cancer Institute
Amsterdam , 1066C, Netherlands
National University Cancer Institute National University Hospital
Singapore , 11907, Singapore
National Cancer Centre Singapore NCCS
Singapore , 16961, Singapore
OncoCare Cancer Centre- Gleneagles Medical Centre
Singapore , 25849, Singapore
Hospital Universitario Virgen Macarena
Sevilla Andalucia, 41009, Spain
Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO
Badalona Cataluã'a, 08916, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
MD Anderson Cancer Center
Madrid , 28033, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Regional Universitario Carlos Haya
Málaga , 29010, Spain
Hospital Clinico Universitario Lozano Bleza
Zaragoza , 50009, Spain
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Niaosong Gao Xiong Shi, 833, Taiwan
National Cheng Kung University Hospital
Tainan City Tai Nan Shi, 704, Taiwan
E-Da Hospital
Kaohsiung City , 824, Taiwan
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Niaosong , 83301, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
Chung Shan Medical University Hospital
Taichung , 420, Taiwan
National Taiwan University Hospital NTUH
Taipei , 100, Taiwan
MacKay Memorial Hospital
Taipei , 10449, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan , 333, Taiwan
University Hospital Birmingham NHS Trust
Birmingham , B9 5S, United Kingdom
The Royal Marsden NHS Foundation Trust
London , E20 1, United Kingdom
University College London Hospitals
London , NW12P, United Kingdom
The Christie Hospital
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

420

Study ID:

NCT04619004

Recruitment Status:

Recruiting

Sponsor:


Daiichi Sankyo, Inc.

How clear is this clinincal trial information?

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