An observational study in Non-small Cell Lung Cancer, sponsored by Boehringer Ingelheim. Not yet recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Boehringer Ingelheim · Observational
This study aims to evaluate the real-world effectiveness and safety of zongertinib across treatment lines and human epidermal growth factor receptor 2 (HER2) mutation subtypes in Japanese patients with HER2-mutated non-small cell lung cancer (NSCLC).
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 300 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with HER2-mutated NSCLC who were receiving outpatient or inpatient care at each participating institution prior to the date of research approval, as well as patients who will receive outpatient or inpatient care between the date of research approval and 31 October 2029.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A) Patients who, or whose legally acceptable representative, provided written for participation B) For patients transferred to another hospital, written informed consent is not mandatory, and registration through verbal informed consent will be permitted C) Patients for whom written or verbal informed consent cannot be obtained because they are deceased or cannot be contacted by the investigators can be enrolled through an opt-out procedure
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Japanese patients with human epidermal growth factor receptor 2 (HER2)-mutated non-small cell lung cancer (NSCLC) have received their first systemic anticancer therapy for metastatic or locally advanced NSCLC.
Drug: Zongertinib
Japanese patients with HER2-mutated NSCLC have received their systemic anticancer therapy administered after one prior line of systemic therapy for metastatic or locally advanced NSCLC.
Drug: Zongertinib
Japanese patients with HER2-mutated NSCLC have received their systemic anticancer therapy administered after two prior lines of systemic therapy for metastatic or locally advanced NSCLC.
Drug: Zongertinib
Zongertinib
Real-world overall response rate (rwORR) in the zongertinib 1L group
Time frame: up to 4.6 years
rwORR in the zongertinib 2L group
Time frame: up to 4.6 years
rwORR in the zongertinib 3L group
Time frame: up to 4.6 years
Real world disease control rate (rwDCR) in the zongertinib 1L, 2L, and 3L groups
Time frame: up to 4.6 years
Real world progression-free survival (rwPFS) in the zongertinib 1L, 2L, and 3L group
Time frame: up to 4.6 years
Real world overall survival (rwOS) in the zongertinib 1L, 2L, and 3L group
Time frame: up to 4.6 years
Real world time-to-treatment failure (rwTTF) in the zongertinib 1L, 2L, and 3L group
Time frame: up to 4.6 years
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →