RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer
Status:
Terminated
Trial end date:
2016-05-25
Target enrollment:
Participant gender:
Summary
This is a study to investigate the potential clinical benefit of roniciclib when given in
combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line
treatment in patients with extensive disease small cell lung cancer. Approximately 140
patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in
combination with chemotherapy.
Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor
targets certain key proteins that are essential for the survival of the cancer cell. The
growth of the tumor may be decreased by preventing these specific proteins from functioning.
By specifically targeting these proteins, roniciclib in combination with chemotherapy may
stop cancer growth.
The primary endpoint (the most meaningful result to be tracked) of this study is based on the
progression free survival, i.e. the time the disease is not worsening. The aim is to show
that the therapy with roniciclib in combination with chemotherapy prolongs the time the
disease is not worsening in this patient population compared to patients receiving placebo in
combination with chemotherapy.