drugset / Trial / NCT02426658

Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3

NCT02426658 ↗

NaSingle-groupOpen-labelTreatment

Summary

This pilot phase II trial studies how well pemetrexed disodium works in treating patients with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG) performance status of 3. Performance status means how well patients are able to perform daily activities and care for themselves. Patients with a performance status of 3 have a limited ability to move around. Currently, only patients who are able to perform most of their daily activities may receive chemotherapy, due to the side effects it may cause. Pemetrexed disodium causes fewer side effects than many chemotherapy drugs and may help treat patients with stage IV non-small cell lung cancer and a lower performance status.

Timeline

Start
2015-05
Primary completion
2018-04-19
Completion
2022-10-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Treatment (Pemetrexed Disodium); p = 0.7044; Mixed Models Analysis NCT02426658 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pemetrexed Small molecule — Intravenous