Actively Recruiting
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-23
14
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out how many people with HER2-amplified or HER2-mutated non-small cell lung cancer (NSCLC) experience a decrease in tumor viability when they receive trastuzumab deruxtecan before routine surgery to remove tumors.
CONDITIONS
Official Title
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older
- Able to follow the study protocol
- Pathologically confirmed NSCLC stage II, IIIA, or selected IIIB
- Molecular testing showing HER2 mutation or amplification
- Tumor measurable by RECIST v1.1 criteria
- Tumors with solid or subsolid appearance on CT (not purely ground-glass opacity)
- Evaluated by surgeon as operable and completely resectable
- Adequate lung function for surgery confirmed by pulmonary tests
- Left ventricular ejection fraction of 50% or higher by echocardiogram
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function by lab tests
- Use of highly effective contraception during and after study if of childbearing potential
- Willingness and ability to comply with study visits and procedures
You will not qualify if you...
- NSCLC stage IIIB due to N3 disease or T4 with mediastinal organ invasion
- Need for total pneumonectomy for complete resection
- Previous lung cancer treatment within 3 years
- Previous lung cancer remission less than 3 years except certain minimal cancers
- History or current interstitial lung disease or pneumonitis needing steroids
- Significant lung diseases such as recent pulmonary embolism, severe asthma, COPD, or pleural effusion
- Autoimmune or inflammatory diseases with lung involvement
- Previous complete pneumonectomy
- Uncontrolled infections requiring IV treatment
- Active immunodeficiency or active HIV or hepatitis B/C infection
- Prolonged QT interval on ECG
- Receipt of live attenuated vaccine within 30 days before treatment
- Allergy or severe reaction to study drug or similar antibodies
- Substance abuse or other conditions increasing safety risk or interfering with study
- Major surgery within 28 days before treatment
- Other cancers within 3 years except certain low-risk types
- Recent treatment with investigational drugs
- History of serious heart conditions
- Social or geographic factors interfering with participation
- Medical conditions increasing toxicity risk
- Pregnant or breastfeeding, or intending pregnancy during study
- Women of childbearing potential must have negative pregnancy test before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of Michigan (Data Collection Only)
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
2
Mayo Clinic (Data Collection Only)
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
3
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
10
Centre Hospitalier de l'Université de Montreal (Data Collection Only)
Montreal, Quebec, Canada, H2L 4M1
Not Yet Recruiting
Research Team
J
James Isbell, MD
CONTACT
J
Jamie Chaft, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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