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Observing Zongertinib Use in Japanese Patients With HER2-Mutated Lung Cancer

Studies zongertinib's real-world safety and effectiveness in adults with HER2-mutated lung cancer.

Plain-language title generated from the registry record
Registry title: Real-world Outcome of Zongertinib in Japan (J-HERZ)

Key facts

Where
Tokyo, JapanSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. 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 12 November 2026.

Where in Japan

  • Nippon Boehringer Ingelheim Co., Ltd.Tokyo, JapanContact: Boehringer IngelheimNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Boehringer Ingelheim
Trial code
NCT07926308
Record updated
9 November 2026
Original description
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).Read full original descriptionShow less

Observational Study of Zongertinib in Patients With HER2-mutated NSCLC in Japan (J-HERZ)

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).

Inclusion: 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.

Exclusion: Patients who have received zongertinib as an investigational drug; Patients for whom first-time zongertinib treatment is on or after fourth line (4L) treatment.

ClinicalTrials.gov NCT07926308