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New targeted therapy aims to outshine standard chemo for HER2-mutant lung cancer

NCT ID NCT05048797

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This phase 3 study tests whether the targeted drug trastuzumab deruxtecan (T-DXd) works better than standard chemotherapy as the first treatment for people with advanced non-small cell lung cancer that has a specific HER2 gene mutation. About 454 adults who have not had prior treatment for their advanced cancer will be randomly assigned to receive either T-DXd or standard care. The main goal is to see how long the cancer stays under control.

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

454 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Jul 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 to 123 years

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 at least 18 years of age * Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease * Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA * Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease * Left ventricular ejection fraction (LVEF) ≥ 50% * Measurable disease assessed by Investigator based on RECIST 1.1 * Protocol-defined adequate organ function including cardiac, renal, hepatic function * ECOG 0-1 * Having tumour tissue available for central testing Exclusion Criteria: * Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy) * Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases * Active autoimmune or inflammatory disorders * Medical history of myocardial infarction within 6 months prior to randomization * History of non-infectious pneumonitis/ILD, current or suspected ILD * Lung-specific intercurrent clinical significant severe illness * Contraindication to platinum-based doublet chemotherapy or pembrolizumab

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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.

Locally advanced or metastatic non-small cell lung cancer

Contacts and locations

Locations

  • Research Site

    Anchorage, Alaska, 99508, United States

  • Research Site

    Los Alamitos, California, 90720, United States

  • Research Site

    Los Angeles, California, 90048, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    San Francisco, California, 94143, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    Silver Spring, Maryland, 20910, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Basking Ridge, New Jersey, 07920, United States

  • Research Site

    Middletown, New Jersey, 07748, United States

  • Research Site

    Montvale, New Jersey, 07645, United States

  • Research Site

    New Brunswick, New Jersey, 08901, United States

  • Research Site

    Commack, New York, 11725, United States

  • Research Site

    Harrison, New York, 10604, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Uniondale, New York, 11553, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15232, United States

  • Research Site

    Dallas, Texas, 75246, United States

  • Research Site

    Linz, 4020, Austria

  • Research Site

    Vienna, 1210, Austria

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Blumenau, 89010-340, Brazil

  • Research Site

    Brasília, 70200-730, Brazil

  • Research Site

    Natal, 59075-740, Brazil

  • Research Site

    Salvador, 40170-110, Brazil

  • Research Site

    São Paulo, 01321-001, Brazil

  • Research Site

    São Paulo, 01327-001, Brazil

  • Research Site

    Uberlândia, 38408-150, Brazil

  • Research Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Research Site

    Brampton, Ontario, L6R 3J7, Canada

  • Research Site

    Toronto, Ontario, M5G 1Z5, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Beijing, 100142, China

  • Research Site

    Beijing, 100730, China

  • Research Site

    Changchun, 130021, China

  • Research Site

    Changsha, 410008, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Chengdu, 611135, China

  • Research Site

    Fuzhou, 350014, China

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    Hangzhou, 310020, China

  • Research Site

    Jinan, 250117, China

  • Research Site

    Kunming, 650101, China

  • Research Site

    Kunming, 650118, China

  • Research Site

    Linhai, 317000, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110016, China

  • Research Site

    Shenzhen, 518020, China

  • Research Site

    Wenzhou, CN-325000, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Xiamen, 361003, China

  • Research Site

    Yangzhou, 225001, China

  • Research Site

    Vejle, 7100, Denmark

  • Research Site

    Bordeaux, 33000, France

  • Research Site

    Dijon, 21079, France

  • Research Site

    Le Mans, 72037, France

  • Research Site

    Lyon, 69373, France

  • Research Site

    Marseille, 13915, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Cologne, 50937, Germany

  • Research Site

    Dresden, 01307, Germany

  • Research Site

    Mainz, 55131, Germany

  • Research Site

    München, 81377, Germany

  • Research Site

    Oldenburg, 26121, Germany

  • Research Site

    Hong Kong, 999077, Hong Kong

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    Jordan, 999077, Hong Kong

  • Research Site

    Bangalore, 560027, India

  • Research Site

    Delhi, 110085, India

  • Research Site

    Hyderabad, 500032, India

  • Research Site

    Mumbai, 400012, India

  • Research Site

    Nashik, 422002, India

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Monza, 20090, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Parma, 43126, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Verona, 37134, Italy

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Okayama, 700-8558, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Sakai, 590-0197, Japan

  • Research Site

    Sapporo, 060-8638, Japan

  • Research Site

    Sendai, 981-0914, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Yonago-shi, 683-8504, Japan

  • Research Site

    Mexico City, '14080, Mexico

  • Research Site

    Mexico City, 03810, Mexico

  • Research Site

    Amsterdam, 1081 HV, Netherlands

  • Research Site

    Groningen, 9700 RB, Netherlands

  • Research Site

    Nijmegen, 6525 GA, Netherlands

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Olsztyn, 10-357, Poland

  • Research Site

    Przemyśl, 37-700, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Cheongju-si, 28644, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Gyeonggi-do, 13620, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Málaga, 29730, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Kaohsiung City, 833, Taiwan

  • Research Site

    Taichung, 40201, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 10048, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Taipei, TAIWAN, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Çankaya, 06680, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Izmir, 35040, Turkey (Türkiye)

  • Research Site

    Kadıkoy/Istanbul, 34722, Turkey (Türkiye)

More trials for these conditions

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