Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer

A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).

Inclusion Criteria:

• Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
• Participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
• At least 1 measurable lesion.
• Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
• Must be able to follow study guidelines and be able to show up for appointments.

Exclusion Criteria:

• Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• Previous treatment with enzastaurin or pemetrexed.
• Concurrent administration of any other antitumor therapy.
• Inability to swallow tablets.
• Pregnant or breastfeeding.