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Beamion LUNG-3: A study to test whether zongertinib helps people with surgically removed, non-small cell lung cancer with HER2 mutations compared with standard treatment
EU CTIS ID: 2025-521284-12-00
What this study is testing
The primary objective of the trial is to demonstrate superiority of zongertinib over SoC based on the log-rank test on DFS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- 2. Patients must be ≥18 years old or over the legal age of consent in their country
- 3. Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
- 4. HER2 mutation: Documented TKD activating HER2 mutations
- 5. Histology and tumor sample: - Histologically confirmed diagnosis of primary NSCLC
- 6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
You likely can't join if
- 1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
- 2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
- 3. Treatment with […] radiation therapy for primary NSCLC
- 4. Co-occurring actionable mutation with approved targeted therapy (e.g. EGFR or ALK)
- 5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known
- 6. History or presence of - Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis - Active infectious disease requiring systemic therapy - Uncontrolled gastrointestinal disorders affecting drug intake/absorption - Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers - Significant and/or uncontrolled cardiovascular abnormalities, QTcF >470 msec, or ejection fraction <50%
See the full eligibility criteria
- 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- 2. Patients must be ≥18 years old or over the legal age of consent in their country
- 3. Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
- 4. HER2 mutation: Documented TKD activating HER2 mutations
- 5. Histology and tumor sample: - Histologically confirmed diagnosis of primary NSCLC
- 6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
- 7. Staging: Pretherapeutic classification not exceeding Stage IIIB
- 8. Performance status and organ function: - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 - Adequate organ function based on laboratory values
- Further inclusion criteria apply.
- 1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
- 2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
- 3. Treatment with […] radiation therapy for primary NSCLC
- 4. Co-occurring actionable mutation with approved targeted therapy (e.g. EGFR or ALK)
- 5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known
- 6. History or presence of - Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis - Active infectious disease requiring systemic therapy - Uncontrolled gastrointestinal disorders affecting drug intake/absorption - Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers - Significant and/or uncontrolled cardiovascular abnormalities, QTcF >470 msec, or ejection fraction <50%
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Mexico
- Singapore
- Brazil
- Chile
- Israel
- Canada
- Japan
- Hong Kong
- Egypt
- United Kingdom
- China
- Turkey
- Argentina
- United States
- Korea, Republic of
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Mexico; Singapore; Brazil; Chile; Israel and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.