Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568939
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
A Study to Assess Adverse Events and How Intravenously IV Infused Telisotuzumab Vedotin ABBV-399 Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-Label Randomized Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing EGFR Wildtype Locally AdvancedMetastatic Non-Squamous Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably Non-small cell lung cancer NSCLC is a solid tumor a disease in which cancer cells form in the tissues of the lung The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC Change in disease activity and adverse events will be assessed
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC Participants will be randomly assigned a treatment of Teliso-V in 1 of 2 arms at an 11 ratio Each group receives intravenous IV infusion of telisotuzumab vedotin Approximately 100 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 40 sites worldwide
Participants will receive IV telisotuzumab vedotin at 1 of 2 doses as part of a 3 year study duration
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC Participants will be randomly assigned a treatment of Teliso-V in 1 of 2 arms at an 11 ratio Each group receives intravenous IV infusion of telisotuzumab vedotin Approximately 100 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 40 sites worldwide
Participants will receive IV telisotuzumab vedotin at 1 of 2 doses as part of a 3 year study duration
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None