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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ClinRé 001-022 (Premier Cancer Care and Infusion Center)
  Fresno, California, United States Recruiting
• OPN Healthcare, Inc.
  Glendale, California, United States Recruiting
• University of California Irvine
  Orange, California, United States Recruiting
• Sutter Health
  Roseville, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Sarcoma Oncology Center
  Santa Monica, California, United States Recruiting

+153 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.