Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• enzastaurin — DRUG
  1125 milligram (mg) loading dose then 500 mg, oral, daily until disease progression
• pemetrexed — DRUG
  500 milligrams per square meter (mg/m\^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles
• carboplatin — DRUG
  Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
• bevacizumab — DRUG
  15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles
• Placebo — DRUG
  oral, daily

Study Details

The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of participants with advanced stage non-small cell lung cancer.

Key Dates

First listed

Sep 21, 2007

Start date

Oct 31, 2007

Status verified

Apr 2021

Primary completion

Feb 28, 2009

Completion

Feb 28, 2009

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A
  Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin
• Placebo Comparator: B
  Pemetrexed + Carboplatin + Bevacizumab + Placebo

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Randomization to measured PD or death from any cause up to 12.2 months ]

Locations (12)

Find similar trials in Bentonville, AR

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