Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Carcinoma

Treatments: Drug: cisplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191620

6952

B9E-LA-S350

Details and patient eligibility

About

The purposes of this study are to determine:

How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer.

The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Histologically or cytologically confirmed diagnosis of NSCLC
• Have provided written informed consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate organ function

Exclusion criteria

• Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC
• Presence of uncontrolled central nervous system (CNS) metastases
• Inability to comply with protocol or study procedures
• Pregnancy
• Breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)