Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099639
Status:
AVAILABLE
Last Update Posted:
2024-07-10
First Post:
2023-10-17
Brief Title:
Medical Access Program for Patritumab Deruxtecan
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
Medical Access Program for Patritumab Deruxtecan HER3 DXd U3-1402
Status:
AVAILABLE
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:
The purpose of this Medical Access Program is to provide access to HER3-DXd for eligible patients with NSCLC who in their treating physicians opinion have an unmet clinical need which cannot be treated with approved and commercially available drugs and who cannot enter a clinical trial prior to commercial availability
Detailed Description:
This is a Medical Access Program which will be available to adult patients in the US with metastatic or locally advanced EGFRm NSCLC who have received at least 2 prior systemic therapies who have no alternative commercially available treatment options and are not able to enter a clinical trial
In this Medical Access Program eligible patients will be treated with HER3-DXd and will continue to receive treatment until any of the following occurs
Disease progression
Unacceptable toxicity
The benefit-risk no longer favors the individual
HER3-DXd becomes commercially available in the US and reimbursement is approved for the concerned indication of the Medical Access Program
Withdrawal of consent
Pregnancy
Physician discretion
Death
In this Medical Access Program eligible patients will be treated with HER3-DXd and will continue to receive treatment until any of the following occurs
Disease progression
Unacceptable toxicity
The benefit-risk no longer favors the individual
HER3-DXd becomes commercially available in the US and reimbursement is approved for the concerned indication of the Medical Access Program
Withdrawal of consent
Pregnancy
Physician discretion
Death
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