Medical Access Program for Patritumab Deruxtecan

Purpose

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.

Condition

  • Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Expanded Access

Recruiting Locations

Highlands Oncology
Springdale 4132093, Arkansas 4099753 72762

Southern California Permanente Medical Group
Los Angeles 5368361, California 5332921 91101

University of Colorado
Aurora 5412347, Colorado 5417618 80045

Yale-New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510

Advent Health
Orlando 4167147, Florida 4155751 32804

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637

Block Medical Center
Skokie 4911600, Illinois 4896861 60077

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503

Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
Detroit 4990729, Michigan 5001836 48201

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

The Washington University
St Louis 4407066, Missouri 4398678 63130

Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901

Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638 14263

Kettering Health Cancer Center
New York 5128581, New York 5128638 10029

The Mount Sinai Hospital- (Icahn School of Medicine)
New York 5128581, New York 5128638 10029

Messino Cancer Center
Asheville 4453066, North Carolina 4482348 28806

Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27710

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213

The Kaiser Permanente Medical Group
Portland 5746545, Oregon 5744337 97227

Texas Oncology
Pearland 4718097, Texas 4736286 77584

Peace Health
Bellingham 5786899, Washington 5815135 98225

More Details

Status
No longer available
Sponsor
Daiichi Sankyo

Study Contact

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