Medical Access Program for Patritumab Deruxtecan

Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)

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.

Study Overview

• Status: Available
• Conditions: Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: HER3-DXd

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

• Study Type: Expanded Access
• Expanded Access Type: Treatment IND/Protocol

Contacts and Locations

• Study Contact: Name: Contact for Program Information; Phone Number: 9089926400; Email: patient.access@bionicalemas.com

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Available
      • Roswell Park Comprehensive Cancer Center
      • Contact: Principal Investigator
  • Oregon
    • Portland, Oregon, United States, 97213
      • Available
      • Providence Portland Medical Center
      • Contact: Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

Description

Inclusion Criteria - Initial Requests

• Written 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 of 0 or 1 at the time of entering the Medical Access Program.
• Adequate levels of bone marrow reserve and organ function
• 7. 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

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 has participated in the HERTHENA-Lung02 'Trial of Patritumab Deruxtecan Initiated in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer' (NCT05338970) clinical trial.
• 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 ILD (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease 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, 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
• 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
• 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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Investigators: Study Director: Program Team Lead, Daiichi Sankyo

Study record dates

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: U3-1402; EGFR-mutated non small cell lung cancer; HER3 DXd
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Patritumab deruxtecan
• Other Study ID Numbers: U31402-0001-EAP-MA