Clinical trial NCT06099639: Medical Access Program for Patritumab Deruxtecan
Official title: Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
Keywords: EGFR-mutated non small cell lung cancer
HER3 DXd
U3-1402
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2023-10-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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 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

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology
state: Arkansas
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Skokie
country: United States
facility: Block Medical Center
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Detroit
country: United States
facility: Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: The Washington University
state: Missouri
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Kettering Health Cancer Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital- (Icahn School of Medicine)
state: New York
city: Asheville
country: United States
facility: Messino Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: The Kaiser Permanente Medical Group
state: Oregon
city: Pearland
country: United States
facility: Texas Oncology
state: Texas
city: Bellingham
country: United States
facility: Peace Health
state: Washington
Study officials:
affiliation: Daiichi Sankyo
name: Program Team Lead
role: STUDY_DIRECTOR
References: