Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Recruiting
Phase 3
Interventional Study
Non-small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 400 (estimated)
- Sponsor
- Boehringer Ingelheim · Industry
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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-appro…
Trial Locations
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Eligibility Criteria
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) m…
Contacts