🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07195695
Recruiting Phase 3

Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

NCT07195695 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2026-01-16
Last updated
2026-09-17

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

ZongertinibPembrolizumabAtezolizumabDurvalumabNivolumab

Zongertinib: Zongertinib

Pembrolizumab: Pembrolizumab

Atezolizumab: Atezolizumab

Durvalumab: Durvalumab

Nivolumab: Nivolumab

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion 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) 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 Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (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. Exclusion criteria: 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. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (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, QT interval corrected for heart rate by Fridericia formula (QTcF) \>470 msec, or ejection fraction \<50% Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (202)

FacilityCityRegionStatus
ClinRé 001-022 (Premier Cancer Care and Infusion Center) Fresno California Recruiting
OPN Healthcare, Inc. Glendale California Recruiting
University of California Irvine Orange California Recruiting
Sutter Health Roseville California Not Yet Recruiting
University of California San Francisco San Francisco California Recruiting
Sarcoma Oncology Center Santa Monica California Recruiting
University of California Los Angeles Santa Monica California Recruiting
Northern California Kaiser Permanente Vallejo California Not Yet Recruiting
George Washington University Cancer Center Washington D.C. District of Columbia Not Yet Recruiting
Mid Florida Hematology and Oncology Center Orange City Florida Recruiting
Piedmont Cancer Institute Atlanta Georgia Recruiting
Northwest Georgia Oncology Centers Marietta Georgia Recruiting
Saint Alphonsus Regional Medical Center - Boise Boise Idaho Not Yet Recruiting
Northwestern University Chicago Illinois Not Yet Recruiting
University of Illinois Hospital and Health Sciences System Chicago Illinois Recruiting
Duly Health and Care - Lisle Lisle Illinois Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Cancer Care Specialists Reno Nevada Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York Recruiting
Memorial Sloan-Kettering Cancer Center New York New York Recruiting
Levine Cancer Institute Charlotte North Carolina Not Yet Recruiting
Durham VA Health Care System Durham North Carolina Not Yet Recruiting
Providence Cancer Institute Portland Oregon Recruiting
Hendrick Health Abilene Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Not Yet Recruiting
Community Cancer Trials of Utah Ogden Utah Recruiting
Virginia Cancer Specialists, PC Fairfax Virginia Recruiting
Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion) CABA Argentina Recruiting
Hospital Britanico de Buenos Aires CABA Argentina Recruiting
Centro Oncologico Korben CABA Argentina Recruiting
Clinica Adventista Belgrano CABA Argentina Recruiting
Instituto Medico Especializado Alexander Fleming Ciudad Autónoma de Bs As Argentina Recruiting
Flinders Medical Centre Bedford Park South Australia Not Yet Recruiting
St John of God Subiaco Hospital Subiaco Western Australia Recruiting
Austin Health Heidelberg Australia Recruiting
Royal North Shore Hospital Sydney Australia Recruiting
Princess Alexandra Hospital Woolloongabba Australia Not Yet Recruiting
Medical University of Innsbruck Innsbruck Austria Not Yet Recruiting
Clinic Floridsdorf Vienna Austria Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Recruiting

+ 162 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile → 📄 Tecentriq (atezolizumab) drug profile → 📄 Imfinzi (durvalumab) drug profile → 📄 Opdivo (nivolumab) drug profile →

More Boehringer Ingelheim trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07195695 on ClinicalTrials.gov ↗ ← All trials in the UK