Randomized, Double-Blind, Placebo-Controlled, Phase 2Study of Gemcitabine and Cisplatin Plus Enzastaurinversus Gemcitabine and Cisplatin Plus Placebo,Followed by Maintenance Enzastaurin or Placebo inChemonaive Patients with Advanced, Unresectable, orMetastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer - ND

• Conditions: Patients with advanced,unresectable, or metastatic (Stage IIIB/IV) NSCLC.; MedDRA version: 6.1Level: PTClassification code 10029521

• Registration Number: EUCTR2006-005306-31-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-09
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

[1] Have histologic or cytologic diagnosis of advanced NSCLC (Stage
IIIB disease with pleural effusion and/or positive supraclavicular
nodes, or Stage IV disease) not amenable to curative treatment
[2] Have measurable disease
[3] Prior radiation therapy is allowed to <25% of the bone marrow
[4] Have a performance status of 0, 1, or 2 on the Eastern Cooperative
Oncology group (ECOG) scale
[5] Have adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[1] Have a second primary malignancy that is clinically detectable at the
time of consideration for study enrollment
[2] Have documented central nervous system (CNS) metastases (except if
adequately treated and stable for at least 4 weeks). Imaging is required
in symptomatic patients to rule out brain or other CNS metastases, but
is not required in asymptomatic patients
[3] Have had myocardial infarction occurring <6 months before inclusion,
uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac
failure not controlled by medications [4] Have peripheral neuropathy of NCI CTCAE Grade 2 or above
[5]Are unable or unwilling to discontinue use of carbamazepine,
phenobarbital, or phenytoin at least 14 days prior to study therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified