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Testing Zongertinib for Advanced Lung Cancer with HER2 Mutations

Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations

Phase 3 Interventional Boehringer Ingelheim · NCT06151574

This study is testing if a new drug called zongertinib can help adults with advanced lung cancer that has HER2 mutations live longer and feel better compared to the standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy, zongertinib
Locations169 sites (Huntsville, Alabama and 168 other locations)
Trial IDNCT06151574 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed for adults with advanced non-small cell lung cancer (NSCLC) who have HER2 mutations and have not yet received systemic therapy. Participants will be randomly assigned to receive either zongertinib, a drug that inhibits HER2 to potentially slow cancer progression, or the current standard treatment of pembrolizumab combined with platinum-pemetrexed chemotherapy. The study aims to determine if zongertinib can provide better outcomes in terms of slowing disease progression and improving survival rates compared to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic non-squamous NSCLC and documented HER2 mutations.

Not a fit: Patients who have already received systemic therapy for their advanced lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with advanced lung cancer harboring HER2 mutations.

How similar studies have performed: Other studies targeting HER2 mutations in lung cancer have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. Signed and dated written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
2. Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC).
4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
5. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor.
6. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy.
7. Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment.
8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summaries of Product Characteristics (SmPC)/Product Information.

Further inclusion criteria apply.

Exclusion criteria:

1. Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except;

   * effectively treated non-melanoma skin cancers
   * effectively treated carcinoma in situ of the cervix
   * effectively treated ductal carcinoma in situ
   * other effectively treated malignancy that is considered cured by local treatment
2. Tumors with targetable alterations with approved available therapy.
3. Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
4. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
5. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement.
6. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.
7. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.
8. Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.

Further exclusion criteria apply.

Where this trial is running

Huntsville, Alabama and 168 other locations

+119 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 Lung Cancer, Non-squamous, Non-small Cell
Last reviewed 2026-06-15 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.