“Currently available second-line chemotherapy has very limited expectations of benefit. This clinical trial explores another treatment option for these patients,” said John Ruckdeschel, Karmanos Cancer Institute, and a clinical investigator for the trial.
The current standards of care in treating recurrent, sensitive small cell lung cancer are a variety of single agent and combination regimens including topotecan, cyclophosphamide, doxorubicin, vincristine, irinotecan, ifosfamide and cisplatin.
Approximately 50 patients with extensive recurrent sensitive small cell lung cancer, who have progressed at least 60 days after completing chemotherapy, are planned to enroll in the phase II trial at various sites in the US, Ukraine and Russia.
The primary efficacy endpoint of the trial is objective response rate. The secondary endpoints of the trial will evaluate duration of response, progression-free survival and overall survival, time to response and various safety and pharmacokinetic parameters. The study will also evaluate the effects of glufosfamide on lung cancer symptoms.