drugset / Trial / NCT01000480

A Study of Pemetrexed and Cisplatin, in Non Small Cell Lung Cancer

NCT01000480 ↗

Phase 2 Completed 90 enrolled Eli Lilly and Company
NaSingle-groupOpen-labelTreatment

Summary

This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.

Timeline

Start
2009-10
Primary completion
2013-01
Completion
2013-07

Outcome

Missed primary endpoint

registry p = 0.0645; maximum likelihood estimate; note: P-value for H0 which compared the investigational regimen to historical data. NCT01000480 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous