On August 26, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) reported that enrollment has been completed in a randomized Phase II study of REOLYSIN in patients with previously treated advanced or metastatic non-small cell lung cancer ("NSCLC") (IND 211) (Press release, Oncolytics Biotech, AUG 26, 2015, View Source [SID:1234507336]). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen’s University in Kingston, Ontario.
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"Non-small cell lung cancer continues to present a significant health risk for patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We would like to thank our colleagues at the NCIC CTG for completing enrolment in this study."
The study is an open-label, randomized, non-blinded, Phase II clinical study of REOLYSIN as a treatment for advanced or metastatic non-small cell lung cancer patients who have received previous chemotherapy. A total of 166 patients were enrolled. Patients with squamous cell histology were randomized to receive either REOLYSIN given in combination with docetaxel (test arm) or docetaxel alone (control arm), while patients with non-squamous cell histology were randomized to receive either REOLYSIN given in combination with pemetrexed (test arm) or pemetrexed alone (control arm).
The primary objective of the trial is to evaluate the effect of REOLYSIN in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic non-small cell lung cancer. The secondary objectives are to determine the tolerability and toxicity of the therapeutic combination; to investigate additional potential measures of efficacy, including progression rates at three months, objective response rate and overall survival; and to explore potential molecular factors predictive of response.
Although accrual is complete, patient follow-up will continue until planned analyses have been conducted.
About NSCLC
The Canadian Cancer Society estimates that 26,600 Canadians will be diagnosed with lung cancer and that 20,900 Canadians are expected to die from the disease in 2015. The American Cancer Society estimates that 221,200 new cases of lung cancer will be diagnosed in the United States and that 158,040 Americans are expected to die from the disease in 2015. Approximately 80% of all lung cancer cases are of the non-small cell type.