NCT01708993

Reolysin in Previously Treated Advanced/Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy

A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if giving reolysin in combination with docetaxel or pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone.

Detailed description

Reolysin is a virus which has been shown to target and destroy cancer cells in laboratory tests. Reolysin has been studied in over 360 cancer patients to find safe doses that can be given and has also undergone testing in combination with docetaxel. Docetaxel and pemetrexed have anticancer activity in certain cancers including lung and they have been approved by Health Canada for the treatment of patients with advanced or metastatic non-small cell lung cancer. Researchers doing this study also want to evaluate the side effects of reolysin when given together with docetaxel or pemetrexed.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed and Reolysin (and safety run-in)	Pemetrexed: 500 mg/m², IV (10 min) - Day 1 every 3 weeks Reolysin: 4.5 x 10\^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
DRUG	Pemetrexed	Pemetrexed: 500 mg/m² IV (10 min) - Day 1 every 3 weeks
DRUG	Docetaxel and Reolysin	Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks Reolysin: 4.5x10\^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
DRUG	Docetaxel	Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks

Timeline

• Start date: 2012-12-10
• Primary completion: 2016-01-26
• Completion: 2018-09-26
• First posted: 2012-10-17
• Last updated: 2023-08-04

Locations

12 sites across 1 country: Canada