EC145 for treatment of non-small cell lung cancer

• Research type

  Research Study

• Full title

  A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive [FR(++)] Second Line NSCLC

• IRAS ID

  105321

• Contact name

  Martin Forster

• Sponsor organisation

  Endocyte, Inc.

• Eudract number

  2012-000966-40

• ISRCTN Number

  n/a

• Research summary

  Lung cancer is the primary cause of cancer-related mortality for both men and women. Approximately 85% of lung cancer cases are due to non-small cell lung cancer (NSCLC). Primary treatment for patients with advanced NSCLC is chemotherapy. However, a significant percentage of patients generally exhibit progression of the disease within 3??6 months after initiating chemotherapy. For NSCLC patients requiring additional therapy, options remain limited and new treatment modalities are needed. This is Phase 2 international study investigating a new experimental drug EC145 and a new agent used for cancer diagnostics (computer tomography scan) called Technetium 99m-EC20 (99mTc-EC20). EC145 binds to a specific molecule, Folate receptor, that can be found in significant amount in tumors, and kills cancer cells. Contrast agent, 99mTc-EC20 is used to confirm that patients have tumors with Folate receptor and can therefore be treated with EC145. The purpose of this study is to test if EC145 is effective when given alone or in combination with standard treatment, docetaxel, in patients with NSCLC that has progressed or recurred (came back) after prior therapy. Before starting treatment participants will have a diagnostics scan using 99mTc-EC20 administered by intravenous injection to confirm that their tumors bear Folate receptor. EC145 will be administered by intravenous injection on Days 1,4, 8 and 11 during Weeks 1 and 2 of a 3-week cycle. Docetaxel will be administered intravenously on Day 1 of a 3-week cycle on Days 1,4, 8 and 11 during Weeks 1 and 2 of a 3-week cycle. Participants will continue treatment until progressive disease or until unacceptable toxicity occurs. After the completion of therapy and the 30-day follow-up period, the participants will be contacted to obtain updates on their overall health status every 3??4 months. Around 180 patients from Europe, USA and other countries are expected to participate in the study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/1209

• Date of REC Opinion

  8 Nov 2012

• REC opinion

  Further Information Favourable Opinion