Small Cell Lung Cancer

An investigator-sponsored study focusing on small cell lung cancer (SCLC), with Dr Vinod Ganju as the principal investigator, is being run as a Phase II trial in Australia. A key aim of the trial is to obtain clinical evidence to determine whether HA-Irinotecan is capable of targeting and eradicating CD44-expressing small cell lung cancer stem cells. A dual objective of this project is to demonstrate that HA-Irinotecan/carboplatin provides a clinically significant benefit (safety and/or efficacy) over irinotecan/carboplatin, in SCLC patients. Details are as follows:


Title:  A Phase II Trial of HA-Irinotecan, a formulation of hyaluronic acid and irinotecan, in the treatment of extensive stage small cell lung cancer and its effect on tumour stem cells.
Sites/Location: ~2 sites in Australia
Study design: 2 arms, 1:1 randomized, blinded, multi-centre study. First 5 patients safety cohort, unblinded
Study Population: First or second-line patients with extensive small cell lung cancer (ESCLC).
Control arm: Irinotecan with carboplatin
Test arm: HA-Irinotecan with carboplatin
Primary endpoint: Safety and tumour stem cell burden on both test and control arms