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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: enzastaurin; Drug: carboplatin; Drug: pemetrexed; Drug: bevacizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00533429

11398

H6Q-MC-S034 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participants or their legal representative must have signed an informed consent document for clinical research
• have laboratory confirmed diagnosis of advanced, nonsquamous cell non-small cell lung cancer (NSCLC) (Stage IIIB or IV disease) which is not curable
• have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than 25% of the bone marrow
• have measurable disease
• have adequate organ function and estimated life expectancy of 12 weeks

Exclusion criteria

• have known central nervous system (CNS) disease; major surgery within 28 days; minor surgery within 7 days; serious concomitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
• have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
• have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
• are pregnant or breast-feeding
• are unable to swallow tablets

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin

Treatment:

Drug: pemetrexed

Drug: carboplatin

Drug: bevacizumab

Drug: enzastaurin

B

Placebo Comparator group

Description:

Pemetrexed + Carboplatin + Bevacizumab + Placebo

Treatment:

Drug: pemetrexed

Drug: carboplatin

Drug: Placebo

Drug: bevacizumab