Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of … (NCT04886804) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
United States, Australia, Austria608 participantsStarted 2021-07-02
Plain-language summary
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.
The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.
The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.
In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.
The participants are in the study for as long as they benefit from and can tolerate treatment.
Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6, 7 and 9) .
* Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment.
* Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).
* Adequate organ function defined as all of the following:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (≥ 1.5 x 10\^3/μL) (≥ 1500/mm\^3); haemoglobin ≥ 9.0 g/dL (≥ 90 g/L) (≥ 5.6 mmol/L); platelets ≥ 100 x 10\^9/L (100 x 10\^3/μL) (100 x 10\^3/mm3) without the use of hematopoietic growth factors within 4 weeks of start of trial medication.
* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
* Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min - calculated using Chronic Kidney Disease Epidemiology (CKD-EPI) formula (≥ 30 mL/min/1.73m² for cohorts 6, 8, and 9).
* Aspartate transaminase (AST) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1 and is no longer actively recruiting — does that mean the dose-finding stage has already happened, and if so, what has been learned so far about the safety and tolerability of zongertinib that might be relevant to my situation?
2Since one of the trial's cohorts specifically measures response in patients with brain metastases using a specialized brain imaging assessment called RANO-BM, does my cancer's pattern of spread make that cohort more or less relevant to discuss as an option?
3The trial was studying dose-limiting toxicities to find the maximum tolerated dose — based on what's been reported so far, what are the side effects of zongertinib that I should be most aware of when weighing this against other HER2-targeted treatments?
4Because this is a Phase 1 trial focused on safety and early response signals rather than proven survival benefit, how does it compare to any standard-of-care HER2-directed therapies that might already be available to me without enrolling in a study?
5Given that the trial is active but no longer recruiting, is there any chance I could still be considered for participation, or are there other open trials studying zongertinib or similar HER2-targeted approaches that my care team thinks would be worth exploring?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase Ia: Maximum Tolerated Dose (MTD)
Timeframe: At the end of Cycle 1 (each cycle is 21 days).
2
Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Timeframe: At the end of Cycle 1 (each cycle is 21 days).
3
Phase Ib - Cohorts 1, 2 and 5 : Objective response (OR) as assessed by central independent review
Timeframe: From the start of the trial treatment until end of month 12, up to 12 months.
4
Phase Ib - Cohorts 3, 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment
Timeframe: From the start of the trial treatment until end of month 12, up to 12 months.
5
Phase Ib: Cohort 4: Objective response according to Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) by central independent review
Timeframe: From the start of the trial treatment until end of month 12, up to 12 months.