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

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

FACILITYZIPCITYSTATE
University of Michigan (Data Collection Only)48109Ann ArborMichigan
Mayo Clinic (Data Collection Only)55905RochesterMinnesota
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activites)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)11553Rockville CentreNew York

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