drugset / Trial / NCT01656551

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

NCT01656551

Phase 3 Unknown 232 enrolled National Cancer Institute, Naples
RandomizedFactorialOpen-labelTreatment

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.

Timeline

Start
2012-08
Primary completion
2024-11
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 60 mg/m2
Subject Gemcitabine Small molecule 1000 mg/m2
Subject Gemcitabine Small molecule 1200 mg/m2
Subject Pemetrexed Small molecule 500 mg/m2