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New drug shows promise for Tough-to-Treat lung cancer

NCT ID NCT04619004

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study tests an experimental drug called patritumab deruxtecan in people with advanced non-small cell lung cancer that has a specific EGFR mutation and has stopped responding to other treatments. About 277 participants will receive the drug to see if it shrinks tumors. The goal is to control the disease, not cure it.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

277 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Jan 2027

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: 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.

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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.

Non-small cell lung cancer metastatic Non-small cell lung cancer with mutation in epidermal growth factor receptor

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Asan Medical Center

    Songpa-gu, Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Province Of Parma, 43126, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Turin, 10043, Italy

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Beijing Cancer Hospital

    Beijing, 100036, China

  • Beth Israel Deaconess Medical Center, Harvard Medical School

    Boston, Massachusetts, 02215, United States

  • Blacktown Hospital

    Blacktown, New South Wales, 2148, Australia

  • CHU Toulouse - Hopital Larrey

    Toulouse, Haute-Garonne, 31059, France

  • Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO

    Badalona, Cataluã'a, 08916, Spain

  • Cedars Sinai

    West Hollywood, California, 90048, United States

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38043, France

  • Centre Leon Berard

    Lyon, Rhone, 69008, France

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

    Niaosong, 83301, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, 420, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195, United States

  • Complex Oncological Center - Russe

    Rousse, 7002, Bulgaria

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • E-Da Hospital

    Kaohsiung City, 824, Taiwan

  • Emory University

    Dunwoody, Georgia, 30338, United States

  • Florida Cancer Specialist-North

    St. Petersburg, Florida, 33770, United States

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists-East

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists-Panhandle

    Tallahassee, Florida, 32308, United States

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133, Italy

  • Fudan University - Shanghai Cancer Center FUSCC

    Shanghai, 200032, China

  • 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

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

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

    Harbin, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Henry Ford Cancer Institute/Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hopital Morvan CHU de Brest

    Brest, 29609, France

  • Hopital Pontchaillou

    Rennes, 35000, France

  • Hospital Clinico Universitario Lozano Bleza

    Zaragoza, 50009, Spain

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009, Spain

  • Humanitas Cancer Center

    Rozzano, 20089, Italy

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558, Japan

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

    Meldola, 47014, Italy

  • Institut Curie

    Paris, 75248, France

  • Jilin Cancer Hospital

    Changchun, 130012, China

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191, Japan

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

    Vienna, 1030, Austria

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim

    Köln, North Rhine-Westphalia, 51109, Germany

  • Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim

    Cologne, 51109, Germany

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • LungenClinic Grosshansdorf

    Großhansdorf, Schleswig-Holstein, 22927, Germany

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • MHAT Serdika

    Sofia, 1303, Bulgaria

  • MHAT Uni Hospital OOD

    Panagyurishte, 4500, Bulgaria

  • MacKay Memorial Hospital

    Taipei, 10449, Taiwan

  • Massachusetts General Hospital (MGH) - Hematology/Oncology

    Boston, Massachusetts, 02114, United States

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33021, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Moores Cancer Center at the UC San Diego Health

    La Jolla, California, 92093, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-0882, Japan

  • National Cancer Center Hospital East

    Chiba, Kashiwa-shi, 277-8577, Japan

  • National Cancer Centre Singapore NCCS

    Singapore, 169610, Singapore

  • National Cheng Kung University Hospital

    Tainan, Tai Nan Shi, 704, Taiwan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1347, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • National Taiwan University Hospital NTUH

    Taipei, 100, Taiwan

  • National University Cancer Institute National University Hospital

    Singapore, 119074, Singapore

  • Netherlands Cancer Institute

    Amsterdam, 1066CX, Netherlands

  • Niigata Cancer Center Hospital

    Chuo Ku Niigata-shi, 961-8566, Japan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • OncoCare Cancer Centre- Gleneagles Medical Centre

    Singapore, 258499, Singapore

  • Pacific Shores Medical Group

    Long Beach, California, 90813, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    Woolloongabba, 4102, Australia

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • START Madrid - Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873, Japan

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • St George Public Hospital

    Kogarah, New South Wales, 2217, Australia

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008, Australia

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • The Cancer Institute Hospital of JFCR

    Ariake, Koto, 135-8550, Japan

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

    Seoul, 06591, South Korea

  • The Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • The Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of College of Medicine Zhejiang University

    Hangzhou, 310003, China

  • The First Hospital of China Medical University

    Shenyang, 110001, China

  • The Royal Marsden NHS Foundation Trust

    London, E20 1JQ, United Kingdom

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

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

    Wuhan, 430022, China

  • Universitaet zu Koeln - Uniklinik Koeln

    Cologne, North Rhine-Westphal, 50937, Germany

  • Universitaet zu Koeln - Uniklinik Koeln

    Cologne, 50931, Germany

  • Universitaire Ziekenhuis Gasthuisberg

    Leuven, 3000, Belgium

  • University Cancer Center

    Dresden, 01307, Germany

  • University College London Hospitals

    London, NW12PG, United Kingdom

  • University Hospital Birmingham NHS Trust

    Birmingham, B9 5SS, United Kingdom

  • University Hospital of Nantes - Thoracic Oncology

    Nantes, Loire-Atlantique, 44000, France

  • University of California at Irvine

    Orange, California, 92868, United States

  • University of Colorado Denver - Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

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

    Chengdu, 610041, China

  • University of Maryland - Marlene and Stewart Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

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

    Charlottesville, Virginia, 22903, United States

  • University of Washington/Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Virginia Cancer Specialist, PC

    Fairfax, Virginia, 22031, United States

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