NCT01656551

MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer

A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non Squamous Advanced, Metastatic or Recurrent NSCLC.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.

Conditions

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

Interventions

Type	Name	Description
DRUG	Gemcitabine
DRUG	Pemetrexed	500 mg/m2 day 1 every 3 weeks
DRUG	Cisplatin	60 mg/m2 day 1 every 3 weeks

Timeline

• Start date: 2012-08-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2012-08-03
• Last updated: 2023-03-24

Locations

48 sites across 1 country: Italy