A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

Summary

The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102.

Timeline

Start

2013-07

Primary completion

2014-06

Completion

2014-06

Outcome

Outcome not reported

Stopped: “The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms”

Publications

• Scagliotti G, Nishio M, Satouchi M, Valmadre G, Niho S, Galetta D, Cortinovis D, Benedetti F, Yoshihara E, Makris L, Inoue A, Kubota K. A phase 2 randomized study of TAS-102 versus topotecan or amrubicin in patients requiring second-line chemotherapy for small cell lung cancer refractory or sensitive to frontline platinum-based chemotherapy. Lung Cancer. 2016 Oct;100:20-23. doi: 10.1016/j.lungcan.2016.06.023. Epub 2016 Jun 27.

Drugs

Indications