Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients

NCT06279728 | Unknown

• 1 other identifier: DS1062-0003-EAP-MA
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic EGFR mutated non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial.

Conditions

EGFRm Advanced Non-Small Cell Lung Cancer; EGFRm Metastatic Non-Small Cell Lung Cancer

Keywords

Dato-DXd; Datopotamab; Datapotamab deruxtecan; Deruxtecan; DS-1062a; Named patient program; Emergency use; Compassionate use; Expanded access program; Medical access program; EGFRm Advanced Non-Small Cell Lung Cancer; EGFRm Metastatic Non-Small Cell Lung Cancer; EGFR mutation; EGFR; Mutation

Interventions

Datopotamab deruxtecan DRUG

6 mg/kg intravenous infusion Q3W (on Day 1 of each 21-day cycle)

Also known as: Dato-DXd, DS-1062a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patientsis aged ≥18 years (follow local regulatory requirements if the legal age of consent for participation is \>18 years old).
• The patient has histologically or cytologically documented advanced or metastatic NSCLC that is not amenable to curative surgery or radiation.
• The patient must have documented AGAs in EGFR (for example, Ex19del, L858R, G719X, S768I or L861Q, either alone or in combination with other EGFR mutations, which may include T790M). Overexpression of EGFR in the absence of activating mutation is not sufficient for enrollment.
• The patient must have progressed on at least 1 EGFR tyrosine kinase inhibitor and platinum-based chemotherapy, either combined or in either sequence.
• The patient has adequate bone marrow reserve and organ function, based on local laboratory data, in the opinion of the treating physician.
• If the patient is a female and of childbearing potential, a negative urine or serum pregnancy test is required at time of treatment initiation request.
• If the patient (male and female) is of reproductive/childbearing potential, they must agree to use a highly effective form of contraception or avoid intercourse during the program and upon completion of this program and for at least 7 months for females and 4 months for males after the last dose of Dato-DXd.
• Starting at the first dose of Dato-DXd, the patient agrees that if they are:
• A male patient, they must not freeze or donate sperm at any time during this program and for at least 4 months after the last dose of Dato-DXd. Preservation of sperm should be considered prior to the first dose of Dato-DXd.
• A female patient, they must not donate, or retrieve for their own use, ova at any time during this program and for at least 7 months after the last dose of Dato-DXd. Preservation of ova should be considered prior to the first dose of Dato-DXd.
• The patient must have a life expectancy of \>3 months as determined by the treating physician.
• The patient is willing and able to provide written informed consent indicating that they understand the purpose of the Medical Access Program and are willing and able to participate.
• Patients who meet any of the following criteria will not be eligible for the Medical Access Program.

You may not qualify if:

• The patient has a history of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or have suspected ILD/pneumonitis that cannot be ruled out by imaging at the time of entering the program.
• The patient has clinically severe respiratory compromise (based on treating physician assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
• Any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to program enrollment, severe asthma, severe chronic obstructive pulmonary disease, moderate to severe restrictive lung disease, or moderate to severe pleural effusion).
• Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), OR
• Prior complete pneumonectomy.
• Patient has clinically significant unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Grade \>1 at start of treatment within the program. Patients with chronic Grade 2 toxicities may be eligible at the discretion of the treating physician after consultation with the Sponsor Medical Approvers or designees within this program.
• Patient has active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Patient has active hepatitis C. (Active hepatitis C is defined by a positive Hep C Ab result, quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay, and an ALT or AST greater than or equal to 2 times the upper limit of normal.)
• Patient has uncontrolled hepatitis B. (Patients with hepatitis B \[positive HBs antigen test\] must meet the following criteria to be eligible: have an HBV-DNA viral load \<2000 IU/mL off treatment or have an HBV-DNA viral load \<2000 IU/mL on oral antiviral therapy for at least 4 weeks and during the participation in the study.)
• The patient has known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled:
• Undetectable viral RNA.
• Cluster of differentiation 4 (CD4)+ count ≥350.
• No history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).
• If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended. Patients must be tested for HIV during the screening period if acceptable by local regulations or an institutional review board (IRB)/ethics committee (EC).
• The patient has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• AstraZeneca: collaborator

Study Sites (14)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

Location

Touro Infirmary - LCMC Health

New Orleans, Louisiana, 70115, United States

Location

University of Maryland Medical Center Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)

Detroit, Michigan, 48201, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Central Care Cancer Center

Bolivar, Missouri, 65613, United States

Location

Overlook Medical Center Medical Diagnostic Associates Atlantic Medical Group

Summit, New Jersey, 07901, United States

Location

New York Cancer & Blood Specialists

New York, New York, 10028, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

University of Texas Southwestern Medical

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital Cancer Center

Houston, Texas, 77030, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Study Officials

• Global Medical Affairs

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

US (14)