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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: pemetrexed; Drug: placebo; Drug: enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530621

9820

H6Q-MC-JCBT (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

Pemetrexed + Enzastaurin

Experimental group

Treatment:

Drug: enzastaurin

Drug: pemetrexed

Pemetrexed + Placebo

Placebo Comparator group

Treatment:

Drug: pemetrexed

Drug: placebo