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Can a smart drug outperform chemo for Hard-to-Treat lung cancer?

NCT ID NCT05338970

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This phase 3 trial compares an experimental drug called patritumab deruxtecan with standard platinum-based chemotherapy in people with a specific type of non-small cell lung cancer that has an EGFR mutation and has progressed after EGFR-targeted therapy. The drug is designed to deliver chemotherapy directly to cancer cells by targeting a protein called HER3. Researchers are measuring how long participants live without their cancer worsening, as well as overall survival, to see if the new approach offers a better option than current chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
patritumab deruxtecan, an experimental antibody-drug conjugate that targets HER3 to deliver chemotherapy directly to cancer cells
What this could lead to
If it works, this could offer a new treatment option for people with EGFR-mutated lung cancer whose tumors have stopped responding to targeted therapies.
What could go wrong
The trial is still testing the drug, and it may not prove better than chemotherapy. Side effects from the drug, including lung inflammation, are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

586 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EGFR exon 19 deletion EGFR L858R Nonsquamous non small cell lung cancer

Contacts and locations

Locations

  • APHP - Hopital Saint Louis

    Paris, 75010, France

  • ASST Sette Laghi

    Varese, 21100, Italy

  • AZ Delta

    Roeselare, 8800, Belgium

  • AZ Sint Maarten Mechelen

    Mechelen, 2800, Belgium

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, 830000, China

  • Akershus University Hospital

    Lørenskog, 1478, Norway

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508, United States

  • American Oncology Partners of Maryland

    Bethesda, Maryland, 20817, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Fachklinik Muenchen-Gauting

    Gauting, 82131, Germany

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Austin Hospital

    Melbourne, 3084, Australia

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, 10043, Italy

  • Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre

    London, EC1A 7BE, United Kingdom

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041, China

  • Centre Francois Baclesse

    Caen, 14076 CEDEX 05, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

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

    Rennes, 35000, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centro Clinico Champalimaud

    Lisbon, 1400-038, Portugal

  • Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio

    Porto, 4099-001, Portugal

  • Centro Hospitalar de Vila Nova de Gaia - Espinho

    Porto, 4434-502, Portugal

  • Chang Gung Memorial Hospital-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • City of Hope

    Duarte, California, 91010, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • E-Da Hospital

    Kaohsiung City, 824, Taiwan

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erasmus MC

    Rotterdam, 3015 CD, Netherlands

  • Fudan University - Shanghai Cancer Center FUSCC

    Shanghai, 200032, China

  • Fujian Medical University - Union Hospital Foochow Christian Union Hospital

    Fuzhou, 350001, China

  • Fujita Health University Hospital

    Toyoake, 470-1192, Japan

  • General Hospital of Eastern Theater Command

    Nanjing, 210002, China

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

    Guangzhou, 510080, China

  • Gustave Roussy

    Villejuif, 94805, France

  • Hackensack Meridian Health-Southern Ocean Medical Center

    Manahawkin, New Jersey, 08050, United States

  • Harbin Medical University - Tumor Hospital The Third Affiliated Hospital

    Harbin, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Henan Provincial Peoples Hospital

    Henan, 450003, China

  • Highlands Oncology

    Springdale, Arkansas, 72762, United States

  • Hopital Morvan CHU de Brest

    Brest, 29609, France

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Regional Universitario Malaga

    Málaga, 29010, Spain

  • Hospital Teresa Herrera C.H.U.A.C.

    A Coruña, 15006, Spain

  • Hospital Univeritario Marques de Valdecilla

    Santander, 39120, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41071, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

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

    Wuhan, 430030, China

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • Hyogo Cancer Center

    Akashi, 673-8558, Japan

  • ICON Cancer Centre

    Singapore, 329563, Singapore

  • IFO Regina Elena

    Roma, 00144, Italy

  • II Klinika Chorob Pluc i Gruzlicy

    Bialystok, 15-450, Poland

  • IKF Krankenhaus Nordwest

    Frankfurt am Main, 60488, Germany

  • IRCCS Humanitas Research Hospital

    Rozzano, 20089, Italy

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • IRCCS Istituto Oncologico Giovanni Paolo II

    Bari, 70124, Italy

  • Innovative Clinical Research Institute

    Whittier, California, 90603, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Institut Curie

    Paris, 75005, France

  • Institut de Cancrologie de lOuest ICO

    Saint-Herblain, 44805, France

  • Instituto Portugues de Oncologio de Lisboa

    Lisbon, 1908-072, Portugal

  • Iwakuni Clinical Center

    Iwakuni, 740-8510, Japan

  • Izumi City General Hospital

    Izumi, 594-0073, Japan

  • Jilin Cancer Hospital

    Changchun, 130021, China

  • Kaiser Permanente - Vallejo Medical Center

    Vallejo, California, 94589, United States

  • Kanazawa University Hospital

    Kanazawa, 920-8641, Japan

  • Kansai Medical University Hospital

    Hirakata, 573-1191, Japan

  • Kantonsspital Graubuenden - Hauptstandort

    Chur, 7000, Switzerland

  • Kantonsspital Winterthur KSW

    Winterthur, 8400, Switzerland

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

    Vienna, 1210, Austria

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511, Japan

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730, Germany

  • Klinikum Klagenfurt Pulmologie

    Klagenfurt, 9020, Austria

  • Klinikum Wels-Grieskirchen

    Wels, 4600, Austria

  • Klinikverbund Allgaeu

    Kempten, 87439, Germany

  • Kurashiki Central Hospital

    Kurashiki, 710-8602, Japan

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • LKI Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800, Austria

  • Leeds Cancer Centre

    Leeds, LS9 7TF, United Kingdom

  • Leiden University Medical Center

    Leiden, 2333ZA, Netherlands

  • Lin Yi Cancer Hospital

    Linyi, 276000, China

  • Liverpool Hospital

    Liverpool, 2170, Australia

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927, Germany

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Matsusaka Municipal Hospital

    Matsusaka, 515-8544, Japan

  • Med Polonia Sp. z o.o.

    Poznan, 60-693, Poland

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020, Austria

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Montpellier Cancer Institute ICM

    Montpellier, 34298, France

  • Moores Cancer Center at the UC San Diego Health

    La Jolla, California, 92037, United States

  • NHO Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • National Cancer Center

    Goyang, 10323, South Korea

  • National Cancer Center Hospital East

    Chibi, 260-0013, China

  • National Cancer Centre Singapore NCCS

    Singapore, 169610, Singapore

  • National Cheng Kung University Hospital NCKUH

    Tainan, 704, Taiwan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • National Taiwan University Hospital NTUH

    Taipei, 100, Taiwan

  • National University Cancer Institute National University Hospital

    Singapore, 119074, Singapore

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX, Netherlands

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Onko-Centrum Sp. z o.o.

    Lublin, 20-250, Poland

  • Oslo University Hospital-The Norwegian Radium Hospital

    Oslo, 0379, Norway

  • Ospedale San Luca

    Lucca, 55100, Italy

  • Ospedale Santa Maria della Misericordia

    Perugia, 06132, Italy

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, 00852, Hong Kong

  • Pecking University Third Hospital

    Haidian, 100191, China

  • Peking University Cancer Hospital

    Beijing, 100142, China

  • Pius-Hospital Oldenburg

    Oldenburg, 26121, Germany

  • Prince of Wales Hospital

    Hong Kong, 999077, Hong Kong

  • Princess Alexandra Hospital

    Woolloongabba, 4102, Australia

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Queen Elizabeth Hospital

    Hong Kong, Hong Kong

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD, Netherlands

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861- 4193, Japan

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Samsung Medical Center

    Seoul, 135-710, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon/Florida Cancer Specialists - FCS South

    Port Charlotte, Florida, 33980, United States

  • Scripps MD Anderson Cancer Center

    La Jolla, California, 92037, United States

  • Sendai Kousei Hospital

    Sendai, 980-0873, Japan

  • Seoul National University Bundang Hospital

    Seongnam, 463-707, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • St George Public Hospital

    Kogarah, 2217, Australia

  • St John of God Subiaco Hospital

    Subiaco, 6008, Australia

  • St Luke's Cancer Institute

    Boise, Idaho, 83712, United States

  • St. Jansdal Ziekenhuis

    Harderwijk, 3844 DG, Netherlands

  • Stavanger University Hospital

    Stavanger, 8100, Norway

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550, Japan

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

    Seoul, 06591, South Korea

  • The Chris O'Brien Lifehouse

    Camperdown, 2050, Australia

  • The Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • The First Affiliate Hospital of Xi'an Jiaotong University

    Xi'an, 710061, China

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

    Hefei, 230022, China

  • The First Affiliated Hospital Sun-Yat-Sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital of College of Medicine Zhejiang University

    Hangzhou, 310003, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021, China

  • The First Hospital of China Medical University

    Shenyang, 110001, China

  • The Royal Marsden Hospital NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP, United Kingdom

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, 650033, China

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126, Germany

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Tokyo, 113-8677, Japan

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • UZ Leuven

    Leuven, 3000, Belgium

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

    Wuhan, 430022, China

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitatsklinik Giessen und Marburg

    Giessen, 35392, Germany

  • University G. D'Annunzio Chieti

    Chieti, 66100, Italy

  • University Hospital Birmingham NHS Trust

    Birmingham, B9 5SS, United Kingdom

  • University Hospitals of Leicester

    Leicester, LE15WW, United Kingdom

  • University Medical Center Utrecht

    Utrecht, 3584 CX, Netherlands

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

    Chengdu, 610041, China

  • University of Hong Kong/Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Wakayama Medical University Hospital

    Wakayama, 641-8509, Japan

  • William Osler Health System - Brampton Civic Hospital

    Brampton, L6R 3J7, Canada

  • Zhejiang Cancer hospital

    Hangzhou, 310022, China

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