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

Eli Lilly and Company160 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Non-small Cell Lung Cancer

Interventions

enzastaurinDRUG

1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression

placeboDRUG

oral, daily

pemetrexedDRUG

500 milligrams per square meter (mg/m\^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS was defined as the time from date of randomization to the first documented observation of disease progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death at the data inclusion cut-off date.

Time frame: Baseline to measured progressive disease up to 9.92 months

Secondary Outcomes

Overall Survival (OS)

OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date the participant was last known to be alive.

Time frame: Baseline to date of death from any cause up to 12.32 months

Time-to-Worsening (TW) in Lung Cancer Symptom Scale (LCSS) - Health Related Quality of Life (HRQoL) Subscale

LCSS is a participant rated lung cancer instrument which consisted of 6 disease related symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 quality of life (QoL) items (activity status, symptomatic distress, and overall QoL). TW in LCSS-HRQoL was measured from the date of enrollment to the first date of a 15 millimeters (mm) worsening in the 9th LCSS item on QoL. LCSS-HRQoL was measured on the 100-mm visual analogue scale (VAS) with the scores ranging from 0 (best response and very high HRQoL) to 100-mm (worse response and very low HRQoL). TW-HRQoL was censored at the date of the participant's last LCSS assessment for participant without a 15-mm increase on the 100-mm VAS.

Time frame: Baseline to disease worsening up to 10.58 months

Duration of Disease Control (DDC)

DDC was defined as the time from randomization to the first documented observation of disease progression or death from any cause and was limited to the participants with a best tumor response of complete response (CR), partial response (PR), or stable disease (SD). Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. SD was defined as small changes that did not meet the above criteria. DDC was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.

Data from ClinicalTrials.gov

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Fayetteville, Arkansas, United States

Lancaster, California, United States

Los Angeles, California, United States

Tampa, Florida, United States

Wichita, Kansas, United States

Scarborough, Maine, United States

Dayton, Ohio, United States

Memphis, Tennessee, United States

Fort Worth, Texas, United States

Richardson, Texas, United States

...and 15 more locations