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 (NCT06151574)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (13 items).
Location: Clearview Cancer Institute — Huntsville, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria:
- 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
- Tumors with targetable alterations with approved available therapy.
- Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
- 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.
- 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.
- 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.
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (163 Sites)
- Clearview Cancer Institute — Huntsville, Alabama
- Pioneer Research Center - Bullhead City — Bullhead City, Arizona
- Precision NextGen Oncology — Beverly Hills, California
- ClinRé 001-022 (Premier Cancer Care and Infusion Center) — Fresno, California
- OPN Healthcare, Inc. — Glendale, California
- Scripps Green Hospital — La Jolla, California
- Valkyrie Clinical Trials — Los Angeles, California
- Sharp Memorial Hospital — San Diego, California
- St. Louis Cancer Care, LLP — Bridgeton, Missouri
- Oncology Hematology Associates — Springfield, Missouri
- Cancer Care Specialists — Reno, Nevada
- Northwell Health — Lake Success, New York
- Montefiore Medical Center — The Bronx, New York
- Regional Medical Oncology Center — Wilson, North Carolina
- Gabrail Cancer Center — Canton, Ohio
- Carolina Blood and Cancer Care Associates, PA — Rock Hill, South Carolina
- SCRI Oncology Partners — Nashville, Tennessee
- Huntsman Cancer Institute — Salt Lake City, Utah
- Virginia Cancer Specialists, PC — Fairfax, Virginia
- Swedish Cancer Institute — Edmonds, Washington
- Swedish Cancer Institute — Issaquah, Washington
- Swedish Cancer Institute — Seattle, Washington
- Clinica Adventista Belgrano — CABA,
- Instituto Medico Especializado Alexander Fleming — Ciudad Autónoma de Bs As,
- Instituto Oncologico de Cordoba — Córdoba,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.