2025-521284-12-00RecruitingPhase 3
Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.16 sites in 4 countries21 target enrollmentStarted: January 19, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 21
- Locations
- 16
- Primary Endpoint
- DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
Study Overview
Brief Summary
The primary objective of the trial is to demonstrate superiority of zongertinib over SoC based on the log-rank test on DFS.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- •Patients must be ≥18 years old or over the legal age of consent in their country
- •Male or female patients. Women of childbearing potential (WOCBP)1 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
- •HER2 mutation: Documented TKD activating HER2 mutations
- •Histology and tumor sample: - Histologically confirmed diagnosis of primary NSCLC
- •An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
- •Staging: Pretherapeutic classification not exceeding Stage IIIB
- •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
- •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 […] radiation therapy for primary NSCLC
- •Co-occurring actionable mutation with approved targeted therapy (e.g. EGFR or ALK)
- •Any investigational drug within 5 half-lives of the compound or any of its related material, if known
- •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, QTcF >470 msec, or ejection fraction <50%
- •Further exclusion criteria apply.
Outcomes
Primary Outcomes
DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
Secondary Outcomes
- OS, defined as the time from randomization until death from any cause
- Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start
Investigators
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
Study Sites (16)
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