Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

Lilly

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: docetaxel; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391274

H3E-MC-JMID (Other Identifier)

10717

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
• At least one prior chemotherapy for palliative therapy
• Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion criteria

• Concurrent administration of any other tumor therapy
• Pregnant or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

Pemetrexed

Experimental group

Treatment:

Drug: pemetrexed

Docetaxel

Active Comparator group

Treatment:

Drug: docetaxel