Trial Information

A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease

PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of
PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision
was made subsequent to DSMC recommendation to close two phase III randomized trials in
non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy,
citing lack of efficacy concerns as the primary reason with safety issues (sepsis,
thrombocytopenia) also contributing to the decision. Subjects were allowed to complete
standard of care treatment and protocol follow-up. Data collection was completed on 31
January 2008.