Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279728
Status:
AVAILABLE
Last Update Posted:
2024-06-07
First Post:
2024-02-19
Brief Title:
Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
Medical Access Program for Datopotamab Deruxtecan Dato-DXd DS-1062a
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 also referred to as an Expanded Access Program in the USA is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer NSCLC who in their treating physicians opinion have an unmet clinical need are unlikely to obtain optimal benefit from currently approved and commercially available drugs and who cannot enter a suitable clinical trial
Detailed Description:
This is a Medical Access Program that will be available to adult patients with previously treated advanced or metastatic nonsquamous NSCLC who have no suitable treatment options and are not able to enter a clinical trial
Patients enrolled in the Medical Access Program can continue treatment until any of the following occurs
Disease progression
Unacceptable toxicity
The benefit-risk no longer favors the individual
Dato-DXd becomes commercially available and reimbursement is approved
The patient chooses to discontinue treatment
Withdrawal of consent
Pregnancy
Physician discretion
Death
Patients enrolled in the Medical Access Program have an option to participate in collection of safety-focused clinical practice data This will contribute towards better understanding of the clinical experience of treatment with Dato-DXd Participation in this optional data collection will have no bearing on receipt of treatment
Patients enrolled in the Medical Access Program can continue treatment until any of the following occurs
Disease progression
Unacceptable toxicity
The benefit-risk no longer favors the individual
Dato-DXd becomes commercially available and reimbursement is approved
The patient chooses to discontinue treatment
Withdrawal of consent
Pregnancy
Physician discretion
Death
Patients enrolled in the Medical Access Program have an option to participate in collection of safety-focused clinical practice data This will contribute towards better understanding of the clinical experience of treatment with Dato-DXd Participation in this optional data collection will have no bearing on receipt of treatment
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