NCT01405586

MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer

Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.

Conditions

• Non-small Cell Lung Cancer Metastatic
• Non-small Cell Lung Cancer Stage IIIB

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
DRUG	Gemcitabine	1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
DRUG	Cisplatin	60 mg/m2 day 1 every 3 weeks for 6 cycles

Timeline

• Start date: 2011-03-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2011-07-29
• Last updated: 2023-03-24

Locations

49 sites across 1 country: Italy