20 November, 2018
Single-use technology, designed for the manufacturing of biopharmaceutical products, has made major inroads over the last 30 years. First introduced in the late 1970s in the form of disposable capsules and a ...
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. 
Last Editorial review: July 29, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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20 November, 2018
05 October, 2018
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published. As research cont...