A Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT02289833)
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. 
- Condition: Non-Small Cell Lung Cancer
- Phase: II
- Estimated Enrollment: 40
- Start: October 2014
- Estimated Completion: June 2016
- Last verified: November 2014
Last Editorial review: July 29, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
Copyright © 2015 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.