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

StatusRecruiting
PhasePhase 3
Started2026-01-16
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
minor
Study Status, Contacts/Locations v22
Study sites202 entries, revised
HôpitalHopital Louis Pradel
2026-08-20
minor
Study Status, Contacts/Locations v21
Trial sites expanded: 198 → 202 locations
2026-08-12
minor
Study Status, Contacts/Locations v20
Study sites199→198
2026-07-23
minor
Study Status, Contacts/Locations v19
Study sitesdetails revised at 9 of 199 sites
2026-07-08
minor
Study Status, Contacts/Locations v18
Study sites200→199
Show 3 earlier versions
2026-06-12
minor
Study Status, Contacts/Locations v17
Study sites199→200
2026-05-29
minor
Study Status, Contacts/Locations v16
Study sites197→199
2026-05-05
minor
Study Identification, Study Status, Study Description, Contacts/Locations v15
Study sites196→197
Study description+1,086 characters
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 perio [...]
Study title-16 characters
Beamion LUNG-3: A Study to Test WhetherAdjuvant Zongertinib Helpsvs Standard Treatment in People With SurgicallyCompletely Removed,Resected NonStage II-smallIIIB CellNSCLC LungHarboring Cancer WithActivating HER2 TKD Mutations Compared With Standard Treatment
2026-04-07
minor
Study Status, Contacts/Locations v14
Trial sites expanded: 192 → 196 locations
2026-03-17
minor
Study Status, Contacts/Locations v13
Study sites198→192
2026-03-04
minor
Study Status, Contacts/Locations v12
Study sites185→198
2026-02-17
minor
Study Status, Contacts/Locations v11
Study sites184→185
2026-02-04
minor
Study Status, Contacts/Locations, IPDSharing, References v10
Study sites178→184
2026-01-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-02-06→confirmed 2026-01-16
Study sites177→178
2026-01-08
minor
Study Status, Contacts/Locations v8
Start date2025-12-29→2026-02-06
Study sites175→177
2025-12-19
minor
Study Status, Contacts/Locations v7
Study sites176→175
2025-12-11
minor
Study Status, Contacts/Locations v6
Start date2025-12-05→2025-12-29
Study sitescontacts updated at 25 of 176 sites
2025-11-25
minor
Study Status, Contacts/Locations v5
Study sites168→176
2025-11-11
minor
Study Status, Contacts/Locations v4
Study sites166→168
2025-10-29
minor
Study Status, Contacts/Locations v3
Study sites159→166
2025-10-15
minor
Study Status, Contacts/Locations v2
Study sites157→159
2025-10-06
minor
Study Status, Contacts/Locations v1
Completion date2034-05-22→2036-09-02
Study sites157 entries, revised
Community Cancer Trials of Utah Hematology Oncology
2025-09-25
minor
Original filing
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.
Trial Details
NCT Number NCT07195695
Lead Sponsor Boehringer Ingelheim
Conditions Non-small Cell Lung Cancer
Enrollment 400 participants
Start Date 2026-01-16
Primary Completion 2032-02-26 (estimated)
Study Completion 2036-09-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-17