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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
EU CTIS ID: 2023-504308-27-00
What this study is testing
The primary objective of the trial is to show superiority of zongertinib (BI 1810631) over SoC (pembrolizumab plus platinum-pemetrexed chemotherapy) based on the hazard ratio of progression-free survival (PFS) in patients diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 TKD mutations who have not received any systemic treatment in this setting. The primary endpoint is PFS per RECIST 1.1 determined by central independent review.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Adequate organ function as defined in the protocol.
- Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.
- "Male or female patients. Women of childbearing potential (WOCBP)1 and men who are able to father a child must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly."
- Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
- Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous NSCLC.
You likely can't join if
- "Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except; i. effectively treated non-melanoma skin cancers ii. effectively treated carcinoma in situ of the cervix iii. effectively treated ductal carcinoma in situ iv. other effectively treated malignancy that is considered cured by local treatment"
- "Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval."
- Further exclusion criteria apply.
- 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.
See the full eligibility criteria
- Signed and dated written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Adequate organ function as defined in the protocol.
- Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.
- "Male or female patients. Women of childbearing potential (WOCBP)1 and men who are able to father a child must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly."
- Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
- Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous NSCLC.
- Documented HER2 mutation in the TKD as per local lab results.
- An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor.
- Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy.
- Presence of at least one measurable non-CNS lesion according to RECIST 1.1, as determined by the local site investigator/radiology assessment.
- "Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information."
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 [R01-0787].
- "Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except; i. effectively treated non-melanoma skin cancers ii. effectively treated carcinoma in situ of the cervix iii. effectively treated ductal carcinoma in situ iv. other effectively treated malignancy that is considered cured by local treatment"
- "Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval."
- Further exclusion criteria apply.
- 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 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."
- Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.
- Mean resting corrected QT interval (QTcF) >470 msec.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Mexico
- Japan
- United States
- Australia
- China
- United Kingdom
- Korea, Republic of
- Singapore
- Hong Kong
- Israel
- Brazil
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Mexico; Japan; United States; Australia; China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.