Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).

This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC.
• ECOG Performance Status 0-2.
• No previous treatment with Docetaxel.
• Measurable Disease.
• Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.
• Adequate liver kidney and bone marrow function.
• Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

• Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Women who are pregnant or lactating.
• Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.
• Serious neurologic or psychiatric disease.
• Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.
• Active uncontrolled infection.