Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung CancerNCT06099639
Medical Access Program for Patritumab Deruxtecan
A study testing HER3-DXd in people with Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer, run by Daiichi Sankyo at 21 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
- What is being tested?
- HER3-DXd
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 21 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- Systemic therapy with at least 1 PBC regimen.
Show all 13Show fewer
- 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.
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Messino Cancer Center
Asheville, North Carolina, 28806
University of Colorado
Aurora, Colorado, 80045
Peace Health
Bellingham, Washington, 98225
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
University of Chicago Medical Center
Chicago, Illinois, 60637
Karmanos Cancer Institute (Barbara Ann Karmanos Cancer Hospital)
Detroit, Michigan, 48201
Duke Cancer Institute
Durham, North Carolina, 27710
Baptist Health Lexington
Lexington, Kentucky, 40503
Southern California Permanente Medical Group
Los Angeles, California, 91101
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Kettering Health Cancer Center
New York, New York, 10029
The Mount Sinai Hospital- (Icahn School of Medicine)
New York, New York, 10029
Advent Health
Orlando, Florida, 32804
Texas Oncology
Pearland, Texas, 77584
Providence Portland Medical Center
Portland, Oregon, 97213
The Kaiser Permanente Medical Group
Portland, Oregon, 97227
Mayo Clinic
Rochester, Minnesota, 55905
Block Medical Center
Skokie, Illinois, 60077
Highlands Oncology
Springdale, Arkansas, 72762
The Washington University
St Louis, Missouri, 63130
Overlook Medical Center
Summit, New Jersey, 07901
About this study
Official title: 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.
Read the 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
- Being tested
- HER3-DXd
- Keywords
- EGFR-mutated non small cell lung cancer, HER3 DXd, U3-1402
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER3-DXdDrug
Also called U3-1402
5.6 mg/kg Q3W [on Day 1 of each 21-day cycle]) infused IV over approximately 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Program Team Lead, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099639
- Sponsor's protocol ID
- U31402-0001-EAP-MA
- Status last verified
- Jun 2025
- First submitted
- 17 Oct 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)
- ClinicalTrials.gov ID
- NCT06099639
- Acronym / sponsor ID
- U31402-0001-EAP-MA
- Keywords
- EGFR-mutated non small cell lung cancer, HER3 DXd, U3-1402
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Documentation of an EGFR-activating mutation detected from tumor tissue or blood (exon 19 deletion or L858R mutation).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HER3-DXdAlso: U3-14025.6 mg/kg Q3W [on Day 1 of each 21-day cycle]) infused IV over approximately 90 minutes | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
Related trials for Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 3
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Non-small Cell Lung Cancer
RecruitingPhase 4
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Stomatitis
Active, not recruitingPhase 1
HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 1/2
First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Non-small Cell Lung Cancer, EGFR Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Program Team Lead study director
Daiichi Sankyo
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HER3-DXd in people with Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer, run by Daiichi Sankyo at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.