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NCT06151574 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Lung Cancer, Non-squamous, Non-small Cell, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 416
- Enrollment target
- 20
- Study locations
NCT06151574 is a Phase 3 study of Lung Cancer, Non-squamous, Non-small Cell that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 416 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT06151574, a Phase 3 study of Lung Cancer, Non-squamous, Non-small Cell, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 416 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG cisplatin
- DRUG carboplatin
- DRUG pemetrexed
- DRUG zongertinib
Study Locations (20)
California
- Precision NextGen Oncology - Beverly Hills
- ClinRé 001-022 (Premier Cancer Care and Infusion Center) - Fresno
- OPN Healthcare, Inc. - Glendale
- Scripps Green Hospital - La Jolla
- Valkyrie Clinical Trials - Los Angeles
- Sharp Memorial Hospital - San Diego
Missouri
- St. Louis Cancer Care, LLP - Bridgeton
- Oncology Hematology Associates - Springfield
New York
- Northwell Health - Lake Success
- Montefiore Medical Center - The Bronx
Alabama
- Clearview Cancer Institute - Huntsville
Arizona
- Pioneer Research Center - Bullhead City - Bullhead City
Nevada
- Cancer Care Specialists - Reno
North Carolina
- Regional Medical Oncology Center - Wilson
Ohio
- Gabrail Cancer Center - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2024-02-09 |
| Est. Completion | 2028-01-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06151574
The ClinicalTrials.gov registry entry for NCT06151574 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lung Cancer, Non-squamous, Non-small Cell appearing as the primary indexed condition, and to 5 interventions - of which pembrolizumab is the first listed.
NCT06151574 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT06151574 about?
NCT06151574 is a clinical study titled "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". 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...
What is the current status of trial NCT06151574?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2024-02-09. Estimated completion is 2028-01-28.
What conditions does trial NCT06151574 study?
This clinical trial studies the following conditions: Lung Cancer, Non-squamous, Non-small Cell.
What interventions are being tested in trial NCT06151574?
The interventions under investigation include: pembrolizumab (DRUG), cisplatin (DRUG), carboplatin (DRUG), pemetrexed (DRUG), zongertinib (DRUG).
Who is sponsoring clinical trial NCT06151574?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06151574 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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