OncoGenex Pharmaceuticals, a biopharmaceutical company, plans to initiate an investigator-sponsored, randomized, double-blind, placebo-controlled phase II study, Spruce, evaluating OGX-427 in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC). The trial will investigate whether adding OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival (PFS) outcomes.
The Spruce trial will randomize approximately 155 patients with non-squamous NSCLC to receive either OGX-427 plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy. Patients may also continue maintenance therapy with pemetrexed and/or OGX-427/placebo until disease progression or unacceptable toxicity. The primary objective will be PFS, with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.
"The majority of patients does not have specific markers for targeted therapy and will still receive broad-spectrum treatments, like chemotherapy. There is an urgent need to improve upon outcomes for these patients," said David Spigel, MD, director of the lung cancer research program, Sarah Cannon Research Institute (SCRI), and the primary investigator on the study. "By targeting Hsp27 with an innovative therapy like OGX-427, we hope we can delay or prevent treatment resistance and extend the overall survival benefit currently provided by chemotherapy."
Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to treatment resistance and more aggressive cancer phenotypes. OGX-427 is a once-weekly intravenous (IV) drug that is designed to inhibit production of Hsp27 to disable cancer cells' defenses and overcome treatment resistance.
Spruce will be the fifth phase II clinical trial evaluating OGX-427 in the treatment of advanced cancers. The study is being sponsored by the SCRI and will be conducted at approximately 20 sites within the SCRI network in the U.S.