drugset / Trial / NCT02613507

Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

NCT02613507 ↗

Phase 3 Completed 504 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether Nivolumab improves life expectancy compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have failed prior platinum-based doublet chemotherapy.

Timeline

Start
2015-12-11
Primary completion
2017-09-15
Completion
2023-11-24

Outcome

Met primary endpoint

registry analysis (superiority test); Nivolumab vs Docetaxel; p = 0.0006; Stratified weighted Log-Rank NCT02613507 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous