Informations générales (source: ClinicalTrials.gov)
Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations
Interventional
Phase 3
Boehringer Ingelheim (Voir sur ClinicalTrials)
février 2024
janvier 2027
27 décembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:11 | Contacter | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CTR Leon Berard - 69373 - Lyon - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Nord - 13015 - Marseille - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion criteria:
1. Signed and dated written informed consent form (ICF) in accordance with
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local
legislation prior to admission to the trial.
2. 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.
3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic
non-squamous Non-small cell lung cancer (NSCLC).
4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine
kinase domain (TKD) as per local lab results.
5. 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.
6. Patients who have not received any systemic treatment for unresectable, locally
advanced or metastatic disease and are not eligible for curative therapy.
7. Presence of at least one measurable lesion according to Response evaluation criteria
in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology
assessment.
8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy
(i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in
accordance with the Summaries of Product Characteristics (SmPC)/Product Information.
Further inclusion criteria apply.
1. Signed and dated written informed consent form (ICF) in accordance with
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local
legislation prior to admission to the trial.
2. 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.
3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic
non-squamous Non-small cell lung cancer (NSCLC).
4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine
kinase domain (TKD) as per local lab results.
5. 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.
6. Patients who have not received any systemic treatment for unresectable, locally
advanced or metastatic disease and are not eligible for curative therapy.
7. Presence of at least one measurable lesion according to Response evaluation criteria
in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology
assessment.
8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy
(i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in
accordance with the Summaries of Product Characteristics (SmPC)/Product Information.
Further inclusion criteria apply.
1. 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
2. Tumors with targetable alterations with approved available therapy.
3. Lung-specific intercurrent clinically significant severe illness based on
investigators assessment.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
Further exclusion criteria apply.