MedPath

Medical Access Program for Patritumab Deruxtecan

Conditions
Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
Registration Number
NCT06099639
Lead Sponsor
Daiichi Sankyo
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

Recruitment & Eligibility

Status
AVAILABLE
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (21)

The Washington University

🇺🇸

Saint Louis, Missouri, United States

Highlands Oncology

🇺🇸

Springdale, Arkansas, United States

Southern California Permanente Medical Group

🇺🇸

Los Angeles, California, United States

University of Colorado

🇺🇸

Aurora, Colorado, United States

Yale-New Haven Hospital

🇺🇸

New Haven, Connecticut, United States

Advent Health

🇺🇸

Orlando, Florida, United States

University of Chicago Medical Center

🇺🇸

Chicago, Illinois, United States

Block Medical Center

🇺🇸

Skokie, Illinois, United States

Baptist Health Lexington

🇺🇸

Lexington, Kentucky, United States

Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)

🇺🇸

Detroit, Michigan, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Overlook Medical Center

🇺🇸

Summit, New Jersey, United States

Roswell Park Comprehensive Cancer Center

🇺🇸

Buffalo, New York, United States

Kettering Health Cancer Center

🇺🇸

New York, New York, United States

The Mount Sinai Hospital- (Icahn School of Medicine)

🇺🇸

New York, New York, United States

Messino Cancer Center

🇺🇸

Asheville, North Carolina, United States

Duke Cancer Institute

🇺🇸

Durham, North Carolina, United States

Providence Portland Medical Center

🇺🇸

Portland, Oregon, United States

The Kaiser Permanente Medical Group

🇺🇸

Portland, Oregon, United States

Texas Oncology

🇺🇸

Pearland, Texas, United States

Peace Health

🇺🇸

Bellingham, Washington, United States

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