Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
Public ClinicalTrials.gov record NCT06151574. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.
Study identification
- NCT ID
- NCT06151574
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 428 participants
Conditions and interventions
Conditions
Interventions
- zongertinib Drug
- pembrolizumab Drug
- cisplatin Drug
- carboplatin Drug
- pemetrexed Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 8, 2024
- Primary completion
- Sep 1, 2026
- Completion
- Jan 27, 2028
- Last update posted
- Aug 19, 2026
2024 – 2028
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | — |
| Pioneer Research Center - Bullhead City | Bullhead City | Arizona | 86442 | — |
| Precision NextGen Oncology | Beverly Hills | California | 90212 | — |
| ClinRé 001-022 (Premier Cancer Care and Infusion Center) | Fresno | California | 93710 | — |
| OPN Healthcare, Inc. | Glendale | California | 91203 | — |
| Scripps Green Hospital | La Jolla | California | 92037 | — |
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| St. Louis Cancer Care, LLP | Bridgeton | Missouri | 63044 | — |
| Oncology Hematology Associates | Springfield | Missouri | 65807 | — |
| Cancer Care Specialists | Reno | Nevada | 89511 | — |
| Northwell Health | Lake Success | New York | 11042 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Regional Medical Oncology Center | Wilson | North Carolina | 27893 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Carolina Blood and Cancer Care Associates, PA | Rock Hill | South Carolina | 29732 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Swedish Cancer Institute | Edmonds | Washington | 98026 | — |
| Swedish Cancer Institute | Issaquah | Washington | 98029 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 141 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06151574, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06151574 live on ClinicalTrials.gov.