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ACTIVE NOT RECRUITING

NCT05338970

PHASE3

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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 suggests that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

586

Start Date

2022-07-08

Completion Date

2026-12-31

Last Updated

2026-08-27

Healthy Volunteers

Conditions

Nonsquamous Non-small Cell Lung Cancer EGFR L858R EGFR Exon 19 Deletion

Interventions

DRUG

Patritumab Deruxtecan

Intravenous administration, 5.6 mg/kg every 3 weeks (q3W).

DRUG

Platinum-based chemotherapy

Intravenous, pemetrexed 500 mg/m\^2 plus either cisplatin (75 mg/m\^2) or carboplatin (target area under the plasma concentration time curve of 5 \[AUC5\] by using the Calvert formula) q3W.

Inclusion Criteria: 1. 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). 2. Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation. 3. Has documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter. 4. Received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a third -generation EGFR TKI. 5. May have received either neoadjuvant and/or adjuvant treatment if progression to metastatic or locally advanced disease occurred at least 12 months after the last dose of such therapy and subsequently experienced disease progression on or after third-generation EGFR TKI treatment administered in the metastatic or locally advanced setting. 6. Has not received any other prior systemic therapies in the metastatic or locally advanced setting (including chemotherapy, immunotherapy etc) (even if administered in combination with EGFR TKI). 7. Has documentation of radiographic disease progression while receiving or after receiving a third generation EGFR TKI for metastatic or locally advanced disease. 8. Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment. 9. Is willing to have a tumor biopsy or provide recently obtained tumor tissue. 10. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. 11. Has adequate bone marrow reserve and organ function based on local laboratory evaluation within 14 days prior to randomization: * Platelet count: ≥100,000/mm\^3 or ≥100 × 10\^9/L within 14 days prior to the assessment of platelet count during the Screening Period * Absolute neutrophil count: ≥1500/mm\^3 or ≥1.5 × 10\^9/L within 14 days prior to the assessment of absolute neutrophil count during the Screening Period * Hemoglobin (Hgb): ≥9.0 g/dL within 14 days prior to the assessment of hemoglobin during the Screening Period * Creatine clearance (CrCl): CrCl ≥45 mL/min calculated by using the Cockcroft-Gault equation or measured CrCl * Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): AST/ALT ≤3× Upper limit of normal (ULN) * Total bilirubin (TBL): TBL ≤1.5 × ULN * Serum albumin: ≥2.5 g/dL * Prothrombin time (PT) or Prothrombin time-International normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT): ≤1.5 × ULN, except for participants receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy who must have PT-INR within therapeutic range as deemed appropriate by the Investigator Exclusion Criteria: 1. 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. 2. Has any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during Screening. 3. Has clinically severe respiratory compromise (based on the Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to the following: * Any underlying pulmonary disorder, restrictive lung disease, or pleural effusion * Any autoimmune, connective tissue, or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of Screening * OR prior complete pneumonectomy 4. Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization. 5. Has any history of or evidence of current leptomeningeal disease. 6. Has evidence of clinically active spinal cord compression or brain metastases, defined as being symptomatic and untreated, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. 7. Any prior treatment with any agent including an antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I, human epidermal growth factor receptor 3 (HER3) antibody, and any systemic therapies (other than EGFR TKIs) in the metastatic/locally advanced setting, including chemotherapy or any other systemic therapy in combination with an EGFR TKI. 8. Has history of other active malignancy within 3 years prior to randomization, except for adequately resected nonmelanoma skin cancer, adequately treated intraepithelial carcinoma of the cervix, and any other curatively treated in situ disease. 9. Has uncontrolled or significant cardiovascular disease prior to randomization. 10. Has active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of randomization. 11. Has a known human immunodeficiency virus (HIV) infection that is not well controlled. 12. Has clinically significant corneal disease.

Locations (182)

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Highlands Oncology

Springdale, Arkansas, United States

City of Hope

Duarte, California, United States

Moores Cancer Center at the UC San Diego Health

La Jolla, California, United States

Scripps MD Anderson Cancer Center

La Jolla, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente - Vallejo Medical Center

Vallejo, California, United States

Innovative Clinical Research Institute

Whittier, California, United States

Sarah Cannon/Florida Cancer Specialists - FCS South

Port Charlotte, Florida, United States

Emory University

Atlanta, Georgia, United States

St Luke's Cancer Institute

Boise, Idaho, United States

American Oncology Partners of Maryland

Bethesda, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hackensack Meridian Health-Southern Ocean Medical Center

Manahawkin, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

The Chris O'Brien Lifehouse

Camperdown, Australia

St George Public Hospital

Kogarah, Australia

Liverpool Hospital

Liverpool, Australia

Austin Hospital

Melbourne, Australia

St John of God Subiaco Hospital

Subiaco, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Klinikum Klagenfurt Pulmologie

Klagenfurt, Austria

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

Vienna, Austria

Klinikum Wels-Grieskirchen

Wels, Austria

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

AZ Sint Maarten Mechelen

Mechelen, Belgium

AZ Delta

Roeselare, Belgium

William Osler Health System - Brampton Civic Hospital

Brampton, Canada

Peking University Cancer Hospital

Beijing, China

Jilin Cancer Hospital

Changchun, China

Hunan Cancer Hospital

Changsha, China

University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital

Chengdu, China

National Cancer Center Hospital East

Chibi, China

Fujian Medical University - Union Hospital Foochow Christian Union Hospital

Fuzhou, China

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

Guangzhou, China

The First Affiliated Hospital Sun-Yat-Sen University

Guangzhou, China

Pecking University Third Hospital

Haidian, China

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, China

Zhejiang Cancer hospital

Hangzhou, China

Harbin Medical University - Tumor Hospital The Third Affiliated Hospital

Harbin, China

The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology

Hefei, China

Henan Provincial Peoples Hospital

Henan, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, China

Lin Yi Cancer Hospital

Linyi, China

General Hospital of Eastern Theater Command

Nanjing, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Fudan University - Shanghai Cancer Center FUSCC

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

The First Hospital of China Medical University

Shenyang, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, China

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

Wuhan, China

Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH

Wuhan, China

The First Affiliate Hospital of Xi'an Jiaotong University

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

Hopital Morvan CHU de Brest

Brest, France

Centre Francois Baclesse

Caen, France

Centre Francois Baclesse

Caen, France

Centre Leon Berard

Lyon, France

Montpellier Cancer Institute ICM

Montpellier, France

Institut Curie

Paris, France

APHP - Hopital Saint Louis

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou

Rennes, France

Institut de Cancrologie de lOuest ICO

Saint-Herblain, France

Gustave Roussy

Villejuif, France

Universitaetsklinikum Essen

Essen, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

IKF Krankenhaus Nordwest

Frankfurt am Main, Germany

Asklepios Fachklinik Muenchen-Gauting

Gauting, Germany

Universitatsklinik Giessen und Marburg

Giessen, Germany

LungenClinic Grosshansdorf

Großhansdorf, Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

LKI Lungenfachklinik Immenhausen

Immenhausen, Germany

Klinikverbund Allgaeu

Kempten, Germany

Pius-Hospital Oldenburg

Oldenburg, Germany

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Prince of Wales Hospital

Hong Kong, Hong Kong

University of Hong Kong/Queen Mary Hospital

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Hong Kong, Hong Kong

IRCCS Istituto Oncologico Giovanni Paolo II

Bari, Italy

University G. D'Annunzio Chieti

Chieti, Italy

Ospedale San Luca

Lucca, Italy

IRCCS Istituto Europeo di Oncologia

Milan, Italy

Asst Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Italy

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

Ospedale Santa Maria della Misericordia

Perugia, Italy

IFO Regina Elena

Roma, Italy

IRCCS Humanitas Research Hospital

Rozzano, Italy

And 82 more locations on ClinicalTrials.gov

Clinical Research Directory

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (182)