Study on Trastuzumab Deruxtecan for People with Non-Small Cell Lung Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT07428044
This clinical trial is exploring how effective trastuzumab deruxtecan is in reducing tumor activity in patients with HER2-amplified or HER2-mutated non-small cell lung cancer (NSCLC) before they undergo surgery to remove the tumors.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to determine how many patients with HER2-amplified or HER2-mutated non-small cell lung cancer (NSCLC) experience a reduction in tumor activity when treated with trastuzumab deruxtecan before their scheduled surgery to remove the tumors.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Able to follow the study procedures.
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) at specific stages (II, IIIA, or selected IIIB).
- Have a HER2 mutation or amplification confirmed by recent lab tests.
- Have measurable disease as defined by medical criteria.
- Tumors must appear solid or subsolid on a CT scan.
- Must be evaluated by a surgeon to confirm that the cancer can be completely removed and that the patient is fit for surgery.
- Have adequate lung function for surgery.
- Have a heart function test showing a left ventricular ejection fraction (LVEF) of 50% or higher.
- Have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate blood and organ function based on specific lab tests.
- Agree to use effective contraception during the study and for at least 4.5 months after the last dose of the study drug.
- Male participants must not donate sperm during the study and for at least 4.5 months after the last dose.
- Female participants must not donate eggs during the study and for at least 7 months after the last dose.
- Willing to attend all study visits and follow procedures.
Exclusion Criteria
- Have NSCLC that has invaded certain organs or is at a more advanced stage.
- Require a total lung removal to achieve complete cancer removal.
- Have had any previous treatment for lung cancer within the last 3 years.
- Have a history of certain lung diseases or conditions that affect lung function.
- Have active infections or immune system disorders.
- Have a history of severe allergic reactions to similar treatments.
- Have had major surgery within the last 28 days.
- Have other cancers within the last 3 years, except for certain low-risk cancers.
- Have heart conditions or other medical issues that could increase risks during the study.
- Be pregnant or breastfeeding, or planning to become pregnant during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Michigan (Data Collection Only) | 48109 | Ann Arbor | Michigan |
| Mayo Clinic (Data Collection Only) | 55905 | Rochester | Minnesota |
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | 11553 | Rockville Centre | New York |
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