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Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
NCT07195695 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow. In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation). Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits. Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, docto
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Atezolizumab
- DRUG Nivolumab
- DRUG Zongertinib
- DRUG Durvalumab
Study Locations (20)
California
- ClinRé 001-022 (Premier Cancer Care and Infusion Center) — Fresno
- OPN Healthcare, Inc. — Glendale
- Sutter Health — Roseville
- Sarcoma Oncology Center — Santa Monica
- University of California Los Angeles — Santa Monica
- Northern California Kaiser Permanente — Vallejo
Illinois
- Northwestern University — Chicago
- University of Illinois Hospital and Health Sciences System — Chicago
- Duly Health and Care - Lisle — Lisle
Georgia
- Piedmont Cancer Institute — Atlanta
- Northwest Georgia Oncology Centers — Marietta
New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York
- Memorial Sloan-Kettering Cancer Center — New York
District of Columbia
- George Washington University Cancer Center — Washington D.C.
Florida
- Mid Florida Hematology and Oncology Center — Orange City
Idaho
- Saint Alphonsus Regional Medical Center - Boise — Boise
Massachusetts
- Dana-Farber Cancer Institute — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-01-16 |
| Est. Completion | 2036-09-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07195695
The ClinicalTrials.gov registry entry for NCT07195695 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07195695 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Illinois, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07195695 about?
NCT07195695 is a clinical study titled "Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment". This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung c...
What is the current status of trial NCT07195695?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2026-01-16. Estimated completion is 2036-09-02.
What conditions does trial NCT07195695 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07195695?
The interventions under investigation include: Pembrolizumab (DRUG), Atezolizumab (DRUG), Nivolumab (DRUG), Zongertinib (DRUG), Durvalumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07195695?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07195695 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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