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Adjuvant zongertinib versus standard adjuvant care for completely resected Stage II–IIIB HER2 TKD–mutant NSCLC

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

Phase 3 Interventional Boehringer Ingelheim · NCT07195695

This trial tests whether taking oral zongertinib after surgery can help adults with completely resected Stage II–IIIB NSCLC whose tumors have activating HER2 TKD mutations live longer without the cancer coming back.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionsradiation, zongertinib, chemotherapy, immunotherapy
Locations197 sites (Fresno, California and 196 other locations)
Trial IDNCT07195695 on ClinicalTrials.gov

What this trial studies

Beamion LUNG-3 is a randomized, open-label Phase 3 trial enrolling adults with completely resected Stage II–IIIB non–small cell lung cancer whose tumors harbor activating HER2 tyrosine kinase domain mutations. After required curative-intent surgery and guideline-directed perioperative systemic therapy, participants are randomized 1:1 to receive oral zongertinib once daily for up to three years or to receive standard adjuvant treatment per local practice (which may include approved adjuvant immunotherapy or observation). The trial's primary endpoint is disease-free survival, with secondary endpoints including overall survival, safety, tolerability, and patient-reported outcomes, and central laboratory confirmation of HER2 status is required. The design is intended to determine whether targeted adjuvant therapy can reduce recurrence compared with current standard approaches.

Who should consider this trial

Good fit: Adults (≥18 years) with completely resected Stage II–IIIB NSCLC harboring activating HER2 TKD mutations who have completed guideline-appropriate neoadjuvant or adjuvant platinum-based systemic therapy are ideal candidates.

Not a fit: Patients without activating HER2 TKD mutations, those with unresectable or metastatic disease, or those who have not completed the required perioperative systemic therapy are unlikely to benefit from this adjuvant-targeted approach.

Why it matters

Potential benefit: If successful, zongertinib could prolong disease-free survival and lower the risk of cancer recurrence for patients with HER2 TKD–mutant resected NSCLC.

How similar studies have performed: While HER2-targeted drugs have shown activity in advanced HER2-mutant lung cancer, adjuvant HER2-targeted therapy is largely unproven and follows the precedent of successful adjuvant targeted approaches in other mutations like EGFR.

Eligibility criteria

Show full inclusion / exclusion 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) 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.

Where this trial is running

Fresno, California and 196 other locations

+147 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.