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

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zongertinib — DRUG
  Zongertinib
• Pembrolizumab — DRUG
  Pembrolizumab
• Atezolizumab — DRUG
  Atezolizumab
• Durvalumab — DRUG
  Durvalumab
• Nivolumab — DRUG
  Nivolumab

Study Details

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.

Key Dates

Start date

Jan 16, 2026

Status verified

May 2026

Primary completion

Feb 26, 2032

Completion

Sep 2, 2036

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zongertinib treatment arm
• Active Comparator: Standard of Care (SoC) treatment arm

Primary Outcome Measure

Disease-free survival (DFS) by investigator's assessment [ Time Frame: up to 8 years and 5 months ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (29)

Find similar trials in Fresno, CA

Related Studies

• Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity
  PHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
  PHASE3 · Recruiting · University of Texas Southwestern Medical Center · La Jolla, California
• VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
  PHASE1/PHASE2 · Recruiting · VM Oncology, LLC · Santa Rosa, California
• Biomarkers for Risk Stratification in Lung Cancer
  Recruiting · University of California, San Francisco · San Francisco, California