Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151574
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-11-22
Brief Title:
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
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1294-1407 | OTHER | None | None |
| 2023-504308-27-00 | REGISTRY | CTIS | None |