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Clin Lung Cancer. 2017 Jan;18(1):92-95. doi: 10.1016/j.cllc.2016.06.014. Epub 2016 Jul 9.

Trastuzumab Emtansine in HER2+ Recurrent Metastatic Non-Small-Cell Lung Cancer: Study Protocol.

Author information

1
Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan. Electronic address: kohashi@cc.okayama-u.ac.jp.
2
Center of Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
3
Department of Medical Oncology, National Hospital Organization Yamaguchi-Ube Medical Center, Yamaguchi, Japan.
4
Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
5
Department of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
6
Department of Pathology, Okayama University Hospital, Okayama, Japan.
7
Department of Clinical Genomic Medicine, Okayama University, Okayama, Japan.
8
Laboratory of DNA Damage Signaling, Department of Late Effects Studies, Radiation Biology Center, Kyoto University, Kyoto, Japan.
9
Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.

Abstract

The treatment outcome has been unsatisfactory for patients with non-small-cell lung cancer (NSCLC) refractory to standard first-line chemotherapy. Trastuzumab emtansine (T-DM1), an anti-HER2 antibody conjugated with a vinca alkaloid, has been approved for clinical use in HER2+ breast cancer in many countries. Approximately 5% of NSCLC tumors possess HER2 alterations, and T-DM1 has shown excellent antitumor effects against HER2+ lung cancer cell lines in preclinical models. Therefore, we hypothesized that T-DM1 could significantly inhibit the growth of HER2+ lung cancers. We have launched a nonrandomized phase II trial of T-DM1 monotherapy for patients with HER2+ lung cancers. The major eligibility criteria are as follows: age ≥ 20 years, pathologically diagnosed NSCLC with documented HER2 positivity (immunohistochemistry 3+, both immunohistochemistry 2+ and fluorescence in situ hybridization positive, or exon 20 insertion mutation), and previous chemotherapy. Thirty patients will receive T-DM1 3.6 mg/kg every 3 weeks. The primary endpoint is the overall response rate. This trial will provide information on whether T-DM1 monotherapy is effective against HER2+ lung cancer.

KEYWORDS:

HER2 amplification; HER2 mutations; HER2 over-expression; NSCLC; Trastuzumab emtansine

PMID:
27497829
DOI:
10.1016/j.cllc.2016.06.014
[Indexed for MEDLINE]

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