Zongertinib / Atezolizumab / Pembrolizumab · Phase 3 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
Beamion LUNG-3 is an ongoing Phase 3 randomized trial comparing zongertinib (an oral HER2 tyrosine kinase inhibitor) to standard adjuvant treatment in adults with completely resected Stage II–IIIB NSCLC harboring HER2 TKD mutations. No results are posted in this registry record; the study is currently recruiting and has not yet reported efficacy or safety data.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-small Cell Lung Cancer; age from 18 Years. Intervention: Zongertinib treatment arm. Compared with: Standard of Care (SoC) treatment arm — Active Comparator. n = 400. 198 sites across 28 countries.
Beamion LUNG-3 is an ongoing Phase 3 randomized trial comparing zongertinib (an oral HER2 tyrosine kinase inhibitor) to standard adjuvant treatment in adults with completely resected Stage II–IIIB NSCLC harboring HER2 TKD mutations. No results are posted in this registry record; the study is currently recruiting and has not yet reported efficacy or safety data.
Blinding status and specific safety monitoring plans are not detailed in the registry text.
This trial will provide the first prospective evidence on whether zongertinib improves disease-free survival as adjuvant monotherapy in HER2-mutant resected NSCLC. Results, when available, may establish a new treatment standard for this molecularly defined population.
This is a Phase 3 trial registration with no posted results; the study is actively recruiting and outcome data are not yet available for analysis.
As stated by the source record.
Quoted from the source exactly as published.
This trial will provide the first prospective evidence on whether zongertinib improves disease-free survival as adjuvant monotherapy in HER2-mutant resected NSCLC. Results, when available, may establish a new treatment standard for this molecularly defined population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07195695). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: Zongertinib; DRUG: Pembrolizumab; DRUG: Atezolizumab; DRUG: Durvalumab; DRUG: Nivolumab. Primary outcome measures: Disease-free survival (DFS) by investigator's assessment , up to 8 years and 5 months. Brief 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.
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