RecruitingPhase 2NCT07428044

A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer

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)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

14 participants

Start Date

Feb 13, 2026

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IIIA

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called trastuzumab deruxtecan (T-DXd) in people with non-small cell lung cancer (NSCLC) that has a specific genetic change (HER2 mutation or amplification). The drug can be used before surgery (neoadjuvant) or after previous treatment. The study aims to see whether T-DXd improves outcomes in this genetically defined group. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with NSCLC at stage II, IIIA, or selected IIIB - Your tumor has a confirmed HER2 mutation or amplification from a certified laboratory - You have not yet had surgery for the current cancer - You are able to follow the study protocol **You may NOT be eligible if...** - Your tumor does not have a HER2 mutation or amplification - Your cancer is at a different stage - You are not well enough to comply with the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, United States

Mayo Clinic (Data Collection Only)

Rochester, Minnesota, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

Centre Hospitalier de l'Université de Montreal (Data Collection Only)

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT07428044

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