Biopharmaceutical company OncoGenex is planning to begin the Spruce clinical trial, evaluating OGX-427 in combination with chemotherapy in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).
The investigator-sponsored, randomised Phase 2 study will assess if the addition of OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival (PFS) outcomes.
The Sarah Cannon Research Institute (SCRI) sponsored study will be conducted at approximately 20 sites within the SCRI network in the US.
The study primary investigator and SCRI lung cancer research programme director David Spigel said that the majority of patients are not having specific markers for targeted therapy and will still receive broad-spectrum treatments, such as chemotherapy.
"There is an urgent need to improve upon outcomes for these patients," Spigel added.
"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."
The fifth Phase 2 clinical trial evaluating OGX-427 in the treatment of advanced cancers will randomise around 155 patients with non-squamous NSCLC with either OGX-427 plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy.
Maintenance therapy with pemetrexed and/or OGX-427 / placebo will be continued in patients until disease progression or unacceptable toxicity.
PFS is the primary objective while the additional analysis will include the evaluation of tumour response rates, overall survival, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.
The company developed OGX-427 as a once-weekly intravenous drug inhibiting Hsp27 production to disable cancer cells’ defences and overcome treatment resistance.