Study on Trastuzumab Deruxtecan for People with Non-Small Cell Lung Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT07428044

Provider View

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.

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