drugset / Trial / NCT02450539

A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

NCT02450539 ↗

Phase 2 Completed 159 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.

Timeline

Start
2015-08-06
Primary completion
2017-03-31
Completion
2020-07-29

Outcome

Missed primary endpoint

registry analysis (superiority test); Abemaciclib vs Docetaxel; p = 0.0068; Hazard Ratio (HR) 1.765 (95% CI 1.165 to 2.672); Stratified log-rank test. NCT02450539 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 200 mg Oral
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous