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New drug shrinks tumors in some Hard-to-Treat lung cancers

NCT ID NCT04644237

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called trastuzumab deruxtecan in 152 people with advanced non-small cell lung cancer that has a specific genetic change (HER2 mutation) and has stopped responding to standard chemotherapy. The drug is given by IV every three weeks and aims to shrink tumors. The main goal was to see how many patients had their tumors shrink significantly.

What this could mean

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

Active substance
trastuzumab deruxtecan (a targeted antibody-drug combination)
What this could lead to
If successful, this could provide a new treatment option for people with a specific genetic subtype of advanced lung cancer that has stopped responding to standard chemotherapy.
What could go wrong
This is a mid-stage trial with only 152 participants, so results may not apply to all patients. The drug can cause serious side effects like lung inflammation, and it is not a cure.

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

152 people

The number who actually took part.

Started

Mar 2021

Finished

Aug 2024

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: * Written informed consent * Men or women ≥18 years, follow local regulatory requirements if the legal age of the consent for study participation is \>18 years * Pathologically documented metastatic NSCLC with a known activating HER2 mutation. Note: A HER2 mutation documented only from a liquid biopsy samples cannot be used for enrollment. * Had previous treatment including platinum therapy in the metastatic/locally advanced setting and not amenable to curative surgery or radiation. Participant must have progressed during or after the last treatment regimen or discontinued because of unacceptable toxicity. * Presence of at least 1 measurable lesion confirmed by the blinded Independent Central Review based on RECIST version 1.1 * Willing and able to provide an archival tumor tissue sample. A fresh biopsy is required if an archival tumor tissue sample cannot be supplied. Resection and core needle biopsy are acceptable. Fine needle aspirates or cell block are not acceptable. * Eastern Cooperative Oncology Group performance status 0 to 1 * Left ventricular ejection fraction ≥ 50% within 28 days before randomization Resection and core needle biopsy are acceptable - Adequate organ function as specified in protocol within 14 days before randomization * Adequate treatment washout period before randomization * Participants of reproductive/childbearing potential agree to use a highly effective form of contraception (or avoid intercourse) during study period and up to 7 months (females) and 4 months (males) after last study dose * Males should not freeze or donate sperm throughout the study period up to at least 4 months after last study dose; females should not donate or retrieve ova for their own use throughout the study period and up to at least 7 months after last study dose * Life expectancy 3 months or more Exclusion Criteria: * Known driver mutation in the epidermal growth factor receptor (EGFR), BRAF, or MET exon 14 gene or a known anaplastic lymphoma kinase (ALK), ROS1, RET, or NTRK fusion * Medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Participants with troponin levels above upper limit of normal at screening (as defined by the manufacturer) and without any myocardial infarction (MI)-related symptoms should have a cardiologic consultation before randomization to rule out MI * Corrected QT interval (QTcF) prolongation \> 470 msec (females) or \>450 msec (males) based on average of the triplicate12-lead electrocardiogram at screening * History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening * Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms * Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated * History of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product * History of severe hypersensitivity reactions to other monoclonal antibodies * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results * Known human immunodeficiency virus (HIV) infection * Known active, clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C) such as those with serologic evidence of viral infection within 28 days of Cycle 1, Day 1 * Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline * Pregnant, breastfeeding, or planning to become pregnant * Otherwise considered inappropriate for the study by the Investigator * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg. pulmonary emboli within three months of the study randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) * Any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening * Prior complete pneumonectomy * Had prior treatment with any agent, including an antibody drug conjugate (ADC), containing a chemotherapeutic agent targeting topoisomerase I

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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

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Aichi Cancer Center Hospital

    Chikusa, 464-8681, Japan

  • Asan Medical Center

    Seoul, 3080, South Korea

  • Assistance Publique Hopitaux de Marseille AP-HM, Hopital NORD

    Marseille, 13015, France

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, 10043, Italy

  • CHU Nantes

    Saint-Herblain, 44800, France

  • CHU toulouse - hôpital Larrey

    Toulouse, 31059, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Chang Gung Memorial Hospital CGMH - LinKou Branch

    Taoyuan, 333, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, 40705, Taiwan

  • Chungbuk National University Hospital

    Taebuk, 28644, South Korea

  • Clinica Univ. de Navarra - P

    Pamplona, 31008, Spain

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Gustav Roussy

    Villejuif, 94800, France

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • Henry Ford Cancer Institute/Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hopital Pontchaillou

    Rennes, 35000, France

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08023, Spain

  • Humanitas Cancer Center Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Strutturadi Oncologia

    Naples, 80131, Italy

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511, Japan

  • Massachusetts General Hospital (MGH) - Hematology/Oncology

    Boston, Massachusetts, 02114, United States

  • National Cancer Center Hospital East

    Kashiwa, 277-0882, Japan

  • National Cancer Central Hospital

    Chūōku, 104-0045, Japan

  • National Cheng Kung University Hospital NCKUH

    Tainan, 704, Taiwan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 11111, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Netherlands Cancer Institute

    Amsterdam, 1066CX, Netherlands

  • Norton Cancer Institute

    Louisville, Kentucky, 40241, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Ospedale San Luca

    Lucca, 55100, Italy

  • Princess Alexandra Hospital

    Woolloongabba, 4102, Australia

  • SC Oncologia, AOU Policlinico Modena

    Modena, 41124, Italy

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Seongnam, 463-707, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St John of God Subiaco Hospital

    Subiaco, 6008, Australia

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • University Health Network

    Toronto, M5G0A3, Canada

  • University of Colorado Denver - Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Detroit, Michigan, 48202, United States

  • Virgina Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.