Trial Title:
Medical Access Program for Patritumab Deruxtecan
NCT ID:
NCT06099639
Condition:
Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Patritumab deruxtecan
Conditions: Keywords:
EGFR-mutated non small cell lung cancer
HER3 DXd
U3-1402
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
HER3-DXd
Description:
5.6 mg/kg Q3W [on Day 1 of each 21-day cycle]) infused IV over approximately 90 minutes
Other name:
U3-1402
Summary:
The purpose of this Medical Access Program is to provide access to HER3-DXd for eligible
patients with NSCLC who, in their treating physician's 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
Criteria for eligibility:
Criteria:
Inclusion Criteria - Initial Requests
- Signed informed consent.
- Male or female aged ≥18 years (or local regulatory requirements).
- Histologically or cytologically documented locally advanced or metastatic EGFRm
NSCLC not amenable to curative surgery or radiation.
- Documentation of radiological disease progression whilst on/after receiving most
recent treatment regimen for locally advanced or metastatic disease. Patients must
have received both of the following:
1. Prior treatment with any EGFR TKI, with at least one of them being osimertinib.
Patients receiving an EGFR TKI at the time of signing informed consent should
continue to take the EGFR TKI until 5 days prior to the first infusion of HER3
DXd.
2. Systemic therapy with at least 1 PBC regimen.
- Documentation of an EGFR-activating mutation detected from tumor tissue or blood
(exon 19 deletion or L858R mutation).
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at the
time of entering the Medical Access Program.
- Adequate levels of bone marrow reserve and organ function, based on local laboratory
data, within 14 days prior to the first HER3-DXd infusion as specified in the MAP
protocol.
- Female patients of childbearing potential must have a negative urine or serum
pregnancy test at the time of entering the Medical Access Program and must be
willing to use highly effective contraception during the treatment period and for at
least 7 months following the last dose of HER3-DXd. Additionally, female patients
must agree to not donate, or retrieve for their own use, eggs from the time of
entering the Medical Access Program and throughout the treatment period, and for at
least 7 months after the final HER3-DXd administration. Male patients with female
partners who are able to become pregnant must be willing to use a highly effective
form of contraception or avoid intercourse during the treatment period and for at
least 4 months following the last dose of HER3- DXd. Additionally, male patients
must agree not freeze or donate sperm from time of entering the Medical Access
Program and throughout the treatment period, and for at least 4 months after final
dose of HER3- DXd.
- Life expectancy of >3 months as determined by the treating physician.
Inclusion Criteria - Resupply Requests
- Treating physician must confirm that the patient is deriving continued benefit from
treatment.
- Treating physician must confirm that all required safety information has been
reported as per local laws/regulations.
Exclusion Criteria - Initial Requests
- Patient is currently participating in or is in follow up for any Daiichi Sankyo ADC
clinical trial including the HERTHENA-Lung02 'Trial of Patritumab Deruxtecan
Initiated in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer'
(NCT05338970).
- Patient has previous or current histologic or cytologic evidence of small cell OR
combined small cell/non-small cell disease in the archival tumor tissue or pre
treatment tumor biopsy.
- Patient has any history of (non-infectious) ILD/pneumonitis that required steroids,
has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out
by imaging at the time of entering the Medical Access Program.
- Patient has clinically severe respiratory compromise (based on treating physician's
assessment) resulting from intercurrent pulmonary illnesses including, but not
limited to: a) any underlying pulmonary disorder, b) any autoimmune, connective
tissue or inflammatory disorders, OR c) prior complete pneumonectomy.
- Inadequate washout period prior to the first HER3-DXd infusion as specified in
protocol.
- Clinically significant unresolved toxicities from previous anticancer therapy,
defined as toxicities (other than alopecia) not yet resolved to National Cancer
Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) Grade ≤1
or baseline. Patients with chronic Grade 2 toxicities may be eligible at the
discretion of the treating physician after consultation with the designated Sponsor
Medical Reviewer.
- Patient has clinically significant and/or uncontrolled cardiovascular disease prior
to the first HER3-DXd infusion.
- Active hepatitis B virus (HBV) and/or hepatitis C virus infection, such as those
with serologic evidence of viral infection within 28 days of the first HER3-DXd
infusion.
- Human immunodeficiency virus (HIV) infection that is not well controlled as
specified in the protocol.
- History of hypersensitivity to either the drug substance or any excipients in
HER3-DXd.
- Female patient who is pregnant, breast-feeding, or intending to become pregnant.
- Prior or ongoing clinically relevant illness, medical condition, surgical history,
physical finding, or laboratory abnormality that, in the treating physician's
opinion, could affect the safety of the patient.
- Clinically significant corneal disease.
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
Note: Patients with localized fungal infections of skin or nails are eligible.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Highlands Oncology
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
University of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Yale-New Haven Hospital
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Advent Health
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Block Medical Center
Address:
City:
Skokie
Zip:
60077
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Baptist Health Lexington
Address:
City:
Lexington
Zip:
40503
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Overlook Medical Center
Address:
City:
Summit
Zip:
07901
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
The Mount Sinai Hospital- (Icahn School of Medicine)
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Messino Cancer Center
Address:
City:
Asheville
Zip:
28806
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
The Kaiser Permanente Medical Group
Address:
City:
Portland
Zip:
97227
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Texas Oncology
Address:
City:
Pearland
Zip:
77584
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Facility:
Name:
Peace Health
Address:
City:
Bellingham
Zip:
98225
Country:
United States
Status:
Available
Contact:
Last name:
Health Care Professional
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099639
