The Principal Investigator is Dr. Alain C. Mita of the CTRC.
“There are significant similarities between SCC lung and SCC head and neck cancers,” said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics. “We are observing clinical benefit in a majority of our SCC head and neck cancer patients treated to date. We have seen clinical responses in metastatic lung lesions with REOLYSIN whether used as a monotherapy or in combination with paclitaxel and carboplatin, and are hopeful that this treatment combination will provide similar benefit to SCC lung cancer patients.”
“This clinical study expands our interests into a variety of lung cancers,” said Dr. Matt Coffey, COO for Oncolytics. “In addition to this study, we are enrolling patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumors in a U.S. Phase 2 clinical trial using REOLYSIN in combination with paclitaxel and carboplatin.”
“The study offers new hope for this group of patients with lung cancer,” said principal investigator Alain C. Mita, M.D., a medical oncologist and assistant professor of medicine at the CTRC at the UT Health Science Center.
The trial (REO 021) is a single arm, open-label, Phase 2 study of REOLYSIN given intravenously with paclitaxel and carboplatin every three weeks. Up to 55 patients are expected to be treated in this trial.
Eligible patients include those with metastatic stage IIIB, or stage IV, or recurrent squamous cell carcinoma of the lung who are chemotherapy naïve for their metastatic or recurrent cancer.
The primary objective of the Phase 2 trial is to assess the antitumor effect of the treatment regimen in the study population in terms of objective response rates. The secondary objectives are to assess progression-free survival and overall survival for the treatment regimen in the study population; to determine the proportion of patients receiving the above treatment who are alive and free of disease progression at six months; and to assess the safety and tolerability of the treatment regimen in the study population.
This trial is part of a broad preclinical and clinical collaboration with the CTRC that will involve up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.