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Brief Title: Medical Access Program for Patritumab Deruxtecan
Official Title: Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)
Study ID: NCT06099639
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Baptist Health Lexington, Lexington, Kentucky, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, 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
Name: Program Team Lead
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR