OncoGenex Pharmaceuticals has initiated the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled phase II trial evaluating OGX-427, a heat shock protein 27 (Hsp27) inhibitor, in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).
Spruce 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 of the trial is progression-free survival (PFS), with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability and the effect of therapy on Hsp27 levels.
"There continues to be an urgent need for a majority of patients with lung cancer who lack specific biomarkers and will receive non-targeted treatments like chemotherapy," said David Spigel M.D., director of the Lung Cancer Research Program, Sarah Cannon Research Institute (SCRI), and the primary investigator on the trial. "We hope opening this trial will lead to us better understanding the role of Hsp27 in non-small cell lung cancer, and the ability of OGX-427 to work with chemotherapies in order to delay or prevent treatment resistance and improve survival outcomes for these patients."
Spruce is sponsored by SCRI and will be conducted at approximately 20 sites within the SCRI network in the U.S.