At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Zongertinib (drug), Pembrolizumab (drug), Atezolizumab (drug), Durvalumab (drug)
- How long the study runs
- Study runs about 128 months (dates as stated)
- About the drug or intervention
- Zongertinib — drug: Zongertinib · Pembrolizumab — drug: Pembrolizumab · Atezolizumab — drug: Atezolizumab · Durvalumab — drug: Durvalumab · Nivolumab — drug: Nivolumab
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 400
- Started
- 2026-01-16
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 400 participants
- • Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Cardiff - Velindre Cancer Centre
- • Edinburgh - Western General Hospital
- • London - Guy's Hospital
- • London - The Royal Marsden Hospital, Chelsea
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.
More detail
This is a global, randomized, open-label, Phase 3 study designed to assess the efficacy and safety of zongertinib as adjuvant therapy in participants with completely resected Stage II-IIIB NSCLC and HER2 TKD-activating mutations. Participants must have undergone complete resection and received perioperative systemic therapy consistent with current standards, including either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. After completing surgery and required systemic treatment, eligible participants are randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years, or standard treatment, which may include an approved adjuvant immunotherapy agent administered according to its label, or observation, depending on local clinical practice and patient status. The primary objective is to evaluate whether zongertinib improves disease-free survival (DFS) compared with standard treatment. Secondary objectives include overall survival (OS), safety, tolerability, and patient-reported outcomes.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Signed and dated written agreement to take part in accordance with ICH-GCP and local legislation prior to admission to the...
- ✓Patients must be ≥18 years old or over the legal age of consent in their country
- ✓HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2)...
- ✓Histology and tumor sample: confirmed by a biopsy diagnosis of primary NSCLC
- ✓An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to...
Who cannot take part
- ✗Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
- ✗Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
- ✗Treatment with radiotherapy for primary NSCLC
- ✗Co-occurring actionable mutation with approved treatment that targets specific changes in the cancer (e.g. Epidermal growth factor receptor (EGFR) or...
- ✗Any investigational drug within 5 half-lives of the compound or any of its related material, if known
See the full criteria
Where Is This Study? (6 UK sites)
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
The Royal Marsden Hospital, Chelsea
London SW3 6JJ, United Kingdom
The Christie Hospital
Manchester M20 4BX, United Kingdom
The Royal Marsden Hospital, Sutton
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT
