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New hope for HER2 lung cancer: targeted drug plus chemo trial launches

NCT ID NCT07486817

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 10 times

Summary

This study tests a new targeted drug called zongertinib, which blocks the HER2 protein that fuels cancer growth, in combination with standard chemotherapy (with or without the immunotherapy pembrolizumab). It is for people with advanced or metastatic non-squamous non-small cell lung cancer that has a HER2 mutation and who have not had prior treatment. The main goal is to see how safe and tolerable the combinations are, with 60 participants randomly assigned to one of two treatment groups.

What this could mean

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

Active substance
zongertinib (a targeted therapy that blocks HER2 protein) combined with platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed), with or without pembrolizumab (an immunotherapy)
What this could lead to
If successful, this could lead to a new first-line treatment option for people with HER2-mutant non-small cell lung cancer, potentially improving tumor control and survival.
What could go wrong
This is an early Phase IIa trial with only 60 participants, so results may not apply to all patients. The combination of drugs may cause significant side effects, and the added benefit of pembrolizumab is not yet known.

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

About 60 people

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

Started

Jun 2026

Expected to finish

Aug 2029

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. Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF) 2. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC) 3. Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result 4. An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status 5. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease 6. Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1 7. Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information 8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further inclusion criteria apply. Exclusion criteria: 1. Tumors with targetable alterations with approved available therapy 2. Presence or history of leptomeningeal disease 3. Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy to regions other than the chest if completed at least 2 weeks prior to treatment start 4. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening 5. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug 6. Previous therapy with a HER2-directed agent 7. History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer, non-squamous, non-small cell

How to take part

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

  1. The places running it

    17 sites in 7 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

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • CTR Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Cabrini Health

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, 510080, China

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Virgen del Rocío

    RECRUITING

    Seville, 41013, Spain

  • INS Curie

    RECRUITING

    Paris, 75005, France

  • Kindai University Hospital

    RECRUITING

    Osaka, Sakai, 590-0197, Japan

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, Chuo-ku, 104-0045, Japan

  • Royal North Shore Hospital

    NOT_YET_RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai Geriatric Medical Center

    RECRUITING

    Shanghai, 201104, China

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69126, Germany

  • Universitätsklinikum Köln (AöR)

    RECRUITING

    Cologne, 50937, Germany

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