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New hope for HER2-positive lung cancer: targeted drug combo enters human testing

NCT ID NCT04686305

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study is testing whether a targeted cancer drug (trastuzumab deruxtecan) combined with immunotherapy and sometimes chemotherapy is safe for people with advanced HER2-positive non-small cell lung cancer. About 304 participants will receive different drug combinations. The main goal is to check for side effects, but researchers will also see if tumors shrink. This is not a cure; the aim is to control the disease.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Jun 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: * Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC * Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. * Part 3, Part 4 and Part 5: Patients must have tumors that do not harbor known genomic alterations or actionable driver kinases, for which approved therapies are available are allowed. * Part 3, Part 4 and Part 5: Patient must be treatment-naïve for advanced or metastatic NSCLC. Patients who have received prior adjuvant, or neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred \> 6 months from end of last therapy * HER2overexpression status as determined by central review of tumor tissue * WHO / ECOG performance status of 0 or 1 * Measurable target disease assessed by the investigator using RECIST 1.1 * Has protocol defined adequate organ and bone marrow function * Part 3, Part 4 and Part 5: Minimum body weight of 35 kg. Exclusion criteria: * HER2 mutation if previously known * Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy * Active primary immunodeficiency known HIV infection, or active chronic and resolved hepatitis B (positive hepatitis B virus surface antigen \[HBsAg+ve\] or hepatitis B virus core antibody (anti-HBc +ve) regardless of HBV DNA level)) or hepatitis C infection. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to treatment assignment if required by local regulations or IRB/EC * Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * 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 * Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke * For Part 3, Part 4 and Part 5: Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class \> II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia are to be excluded. Patients with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before treatment assignment to rule out acute cardiopulmonary events. * Ascites or pericardial effusion that requires drainage, peritoneal shunt, Pleuroperitoneal shunt or CART (Concentrated Ascites Reinfusion Therapy) * For Part 3, Part 4 and Part 5: Active non-infectious skin disease (including any grade rash, urticarial, dermatitis, ulceration, or psoriasis) requiring systemic treatment, active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * Unresolved toxicities not yet resolved to Grade ≤ 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. * must not have any medical contraindication to platinum-based chemotherapy. * Part 3, Part 4 and Part 5 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting. * For Part 3, Part 4 and Part 5: History of substance abuse or any other medical or psychological conditions that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results * For Part 3, Part 4 and Part 5: History of thromboembolic events within 3 months before the first dose of IP (limited to pulmonary embolism, deep vein thrombosis, or cerebral venous sinus thrombosis).

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    54 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    WITHDRAWN

    Duarte, California, 91010, United States

  • Research Site

    WITHDRAWN

    Newport Beach, California, 92663, United States

  • Research Site

    RECRUITING

    Orange, California, 92868, United States

  • Research Site

    WITHDRAWN

    Santa Rosa, California, 95403, United States

  • Research Site

    WITHDRAWN

    Westwood, Kansas, 66205, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Research Site

    WITHDRAWN

    Detroit, Michigan, 48201, United States

  • Research Site

    WITHDRAWN

    Buffalo, New York, 14263, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10029, United States

  • Research Site

    WITHDRAWN

    The Bronx, New York, 10461, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Research Site

    WITHDRAWN

    Tacoma, Washington, 98405, United States

  • Research Site

    TERMINATED

    Adelaide, 5000, Australia

  • Research Site

    WITHDRAWN

    Heidelberg, 3084, Australia

  • Research Site

    RECRUITING

    Nedlands, 6009, Australia

  • Research Site

    COMPLETED

    Edegem, 2650, Belgium

  • Research Site

    RECRUITING

    Barretos, 14784-400, Brazil

  • Research Site

    RECRUITING

    Porto Alegre, 90035-903, Brazil

  • Research Site

    RECRUITING

    São Paulo, 05652-900, Brazil

  • Research Site

    WITHDRAWN

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Research Site

    WITHDRAWN

    London, Ontario, N6A 5W9, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    NOT_YET_RECRUITING

    Changchun, 130000, China

  • Research Site

    NOT_YET_RECRUITING

    Chengdu, 610041, China

  • Research Site

    NOT_YET_RECRUITING

    Fuzhou, 350011, China

  • Research Site

    NOT_YET_RECRUITING

    Shandong, China

  • Research Site

    RECRUITING

    Shanghai, 200433, China

  • Research Site

    NOT_YET_RECRUITING

    Zhengzhou, 450000, China

  • Research Site

    WITHDRAWN

    Bordeaux, 33075, France

  • Research Site

    RECRUITING

    Dijon, 21079, France

  • Research Site

    RECRUITING

    Pierre-Bénite, 69495, France

  • Research Site

    RECRUITING

    Saint-Herblain, 44800, France

  • Research Site

    RECRUITING

    Villejuif, 94805, France

  • Research Site

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Research Site

    RECRUITING

    Tel Litwinsky, 52620, Israel

  • Research Site

    COMPLETED

    Milan, 20133, Italy

  • Research Site

    RECRUITING

    Milan, 20162, Italy

  • Research Site

    RECRUITING

    Monza, 20052, Italy

  • Research Site

    RECRUITING

    Naples, 80131, Italy

  • Research Site

    WITHDRAWN

    Padova, 35128, Italy

  • Research Site

    RECRUITING

    George Town, 10450, Malaysia

  • Research Site

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    RECRUITING

    Kuala Selangor, 62250, Malaysia

  • Research Site

    RECRUITING

    Kuching, 93586, Malaysia

  • Research Site

    COMPLETED

    Amsterdam, 1066 CX, Netherlands

  • Research Site

    RECRUITING

    Bacolod, 6100, Philippines

  • Research Site

    WITHDRAWN

    Cebu City, 6000, Philippines

  • Research Site

    WITHDRAWN

    City of Taguig, 1634, Philippines

  • Research Site

    TERMINATED

    Davao City, PH-8000, Philippines

  • Research Site

    TERMINATED

    Manila, 1000, Philippines

  • Research Site

    WITHDRAWN

    Manila, 1015, Philippines

  • Research Site

    RECRUITING

    Quezon City, 1100, Philippines

  • Research Site

    RECRUITING

    Quezon City, 1112, Philippines

  • Research Site

    TERMINATED

    San Juan City, 1500, Philippines

  • Research Site

    RECRUITING

    Gdansk, 80-214, Poland

  • Research Site

    SUSPENDED

    Krakow, 30-727, Poland

  • Research Site

    RECRUITING

    Olsztyn, 10-357, Poland

  • Research Site

    TERMINATED

    Tomaszów Mazowiecki, 97-200, Poland

  • Research Site

    RECRUITING

    Warsaw, 02-781, Poland

  • Research Site

    COMPLETED

    Singapore, 119228, Singapore

  • Research Site

    COMPLETED

    Singapore, 168583, Singapore

  • Research Site

    COMPLETED

    Singapore, 308433, Singapore

  • Research Site

    RECRUITING

    Cheongju-si, 28644, South Korea

  • Research Site

    RECRUITING

    Goyang-si, 10408, South Korea

  • Research Site

    RECRUITING

    Jinju, 52727, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    WITHDRAWN

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    WITHDRAWN

    Badalona, 08013, Spain

  • Research Site

    WITHDRAWN

    Madrid, 28041, Spain

  • Research Site

    WITHDRAWN

    Seville, 41013, Spain

  • Research Site

    WITHDRAWN

    Valencia, 46010, Spain

  • Research Site

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Research Site

    RECRUITING

    Taichung, 402, Taiwan

  • Research Site

    RECRUITING

    Taichung, 40705, Taiwan

  • Research Site

    RECRUITING

    Tainan, 70403, Taiwan

  • Research Site

    RECRUITING

    Taipei, 100, Taiwan

  • Research Site

    RECRUITING

    Taipei, 11217, Taiwan

  • Research Site

    RECRUITING

    Taipei, 235, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • Research Site

    RECRUITING

    Bangkok, 10300, Thailand

  • Research Site

    COMPLETED

    Bangkok, 10330, Thailand

  • Research Site

    COMPLETED

    Hat Yai, 90110, Thailand

  • Research Site

    COMPLETED

    Khon Kaen, 40002, Thailand

  • Research Site

    NOT_YET_RECRUITING

    Muang, 22000, Thailand

  • Research Site

    RECRUITING

    Muang, 50200, Thailand

  • Research Site

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Ankara, 6200, Turkey (Türkiye)

  • Research Site

    ACTIVE_NOT_RECRUITING

    Bornova-Izmir, 35100, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Istanbul, 31755, Turkey (Türkiye)

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