NCT07926308Not yet recruiting
Real-world Outcome of Zongertinib in Japan (J-HERZ)
Observational Study of Zongertinib in Patients With HER2-mutated NSCLC in Japan (J-HERZ)
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 3 Nov 2026
- Start date
- 17 Nov 2026
- Primary completion date
- 30 Jun 2031
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Lung cancer
- NCT number
- NCT07926308
What you commit to
- Study type: Observational
- Planned participants: 300
- From 17 Nov 2026 to the primary completion date, 30 Jun 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study looks at adults in Japan with advanced lung cancer (non-small cell) that has a HER2 gene change, who have taken or will take zongertinib.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer that has spread (metastatic) or is locally advanced
- Earlier treatment
- Must have received or be scheduled to receive zongertinib as set out in the package insert. Cannot join if zongertinib is first started in fourth line of treatment or later.
- Biomarker or test result
- HER2 mutation confirmed as positive and documented by a medical institution
Main reasons for not taking part
- First zongertinib treatment given in fourth line or later
- Received zongertinib as an investigational drug
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received zongertinib as an investigational drug
Other
- Patients for whom first-time zongertinib treatment is on or after fourth line (4L) treatment
Who the study is looking for
- Patients aged ≥18 years
- Patients with metastatic or locally advanced non-small cell lung cancer (NSCLC)
- Patients confirmed to be human epidermal growth factor receptor 2 (HER2) mutation-positive, as documented by a medical institution
- Patients who have received or are scheduled to receive zongertinib based on the package insert
- Patients who provided consent to participate in the study on or after the date of approval of the study conduct at each participating institution, through one of the following procedures:
- Patients who, or whose legally acceptable representative, provided written informed consent 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.