A Phase II Trial of Neoadjuvant Trastuzumab Deruxtecan for Patients With Stage II-III HER2-Amplified or HER2-Mutated Non-Small Cell Lung Cancer (HERCULES)
Memorial Sloan Kettering Cancer Center
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet the following criteria for study entry: Neoadjuvant Therapy * Signed informed consent form * Age ≥18 years * Able to comply with the study protocol, in the investigator's judgment * Pathologically documented NSCLC o Stage II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion), NSCLC (on the basis of the 8th edition of the AJCC NSCLC staging system) * Note: Patients may be enrolled on the basis of clinical stage, but documentation of nodal involvement by invasive mediastinal staging (e.g., endobronchial ultra…
Interventions
- DrugTrastuzumab Deruxtecan
Trastuzumab deruxtecan (T-DXd, fam-trastuzumab deruxtecan-nxki) is a novel HER2- targeting antibody-drug conjugate (ADC).
Locations (10)
- University of Michigan (Data Collection Only)Ann Arbor, Michigan
- Mayo Clinic (Data Collection Only)Rochester, Minnesota
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)Commack, New York