Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: carboplatin; Drug: pemetrexed; Drug: docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520676

H3E-CR-S380 (Other Identifier)

11626

Details and patient eligibility

About

The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
• Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
• Estimated life expectancy of at least 8 weeks

Exclusion criteria

• Known or suspected brain metastases
• Concurrent administration of any other tumor therapy
• Serious concomitant disorders
• Pregnancy or breast feeding
• 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)

---

260 participants in 2 patient groups

pemetrexed plus carboplatin

Experimental group

Description:

Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum

Treatment:

Drug: pemetrexed

Drug: carboplatin

docetaxel plus carboplatin

Active Comparator group

Description:

Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

Treatment:

Drug: docetaxel

Drug: carboplatin