Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05845671
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-04-25
Brief Title:
Amivantamab With Tyrosine Kinase Inhibitors TKI for Advanced NSCLC With ALK ROS1 or RET Alterations
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Phase 1 2 Open Label Study of Amivantamab JNJ-61186372 Among Participants With Advanced NSCLC Harboring ALK ROS1 and RET Gene Fusions in Combination With Tyrosine Kinase Inhibitors
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:
Although non-small cell lung cancer NSCLC patients with anaplastic lymphoma kinase ALK c-ros oncogene 1ROS1 and ret proto-oncogene RET gene fusions initially respond well to tyrosine kinase inhibitor TKI therapies acquired resistance is inevitable In many of these cases increased activation of the erythroblastic leukemia viral oncogene homologue ERBB or cMet pathways appears to be a bypass signaling mechanism that allows these cancer cells to circumvent the selective pressure from TKIs Recent data have suggested that these pathways compensate for each other in situations where one pathway is inhibited leading to kinase switch drug resistance Thus the expected inhibition of both pathways via treatment with the amivantamab and combination TKI combination may improve overall efficacy by limiting the compensatory pathway activation
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 |
|---|---|---|---|
| 61186372LUC2005 | OTHER | Janssen Scientific Affairs LLC | None |