Lung Cancer Clinical Trial: Lenvatinib (E7080) for KIF5B-RET-Positive NSCLC

• November 27, 2015
• 1 min read

A Phase 2 clinical trial evaluating lenvatinib (E7080), a targeted therapy agent, in KIF5B-RET-positive lung cancer patients is being conducted across Taiwan, Japan, the United States, Hong Kong, and Thailand.

Trial Period: April 2013 – April 2016 Target Enrollment: At least 20 subjects with KIF5B-RET translocation

Eligibility Criteria:

1. Age 18 or older
2. Diagnosed with lung cancer
3. KIF5B or RET translocation confirmed
4. Able to receive treatment
5. Measurable tumor by RECIST 1.1 criteria
6. Blood pressure controlled
7. Performance status (PS) 0 or 1

Exclusion Criteria:

1. Received other anti-tumor agents within 21 days prior to first lenvatinib dose
2. Severe unrecovered adverse events from prior anti-tumor therapy
3. Serious cardiac disease
4. Gastrointestinal dysfunction
5. Surgery within 3 weeks prior to first lenvatinib dose

Trial Description (English):

This is a Phase 2, open-label, safety and activity study of lenvatinib in subjects with KIF5B-RET-positive adenocarcinoma of the lung and other confirmed RET translocations. At least 20 subjects with KIF5B-RET will be treated and will receive lenvatinib at a starting dose of 24 mg orally, once per day. Additional subjects with other RET translocations will be treated with lenvatinib at a starting dose of 24 mg orally, once per day. (ClinicalTrials.gov)

Source: http://www.eisai.co.jp/news/news201435pdf.pdf

Lung Cancer | RET-Positive | Targeted Therapy | Lenvatinib

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