NCT02289833 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT02289833)

Trial Description
This is a Phase 2, multicenter, single-arm, two cohort study designed to evaluate the efficacy and safety of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) as single-agent in patients with HER2-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients will be enrolled into two separate cohorts, depending on HER2 status: HER2 immunohistochemistry (IHC) 2+ or HER2 IHC 3+. Patients in both cohorts will be treated with an intravenous dose of 3.6 mg/kg trastuzumab emtansine on Day 1 of 21-day cycles. Patients will remain on study until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.

This trial is sponsored by F. Hoffmann-La Roche. [1]

Study Data

  • Condition: Non-Small Cell Lung Cancer
  • Interventions:
    • Drugs used in this trial
  • Phase: II
  • Estimated Enrollment: 40
  • Start: October 2014
  • Estimated Completion: June 2016
  • Last verified: November 2014

Study Schematic

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Last Editorial review: July 29, 2015
Information based on (NIH/NCI) and other sources.

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