Overview

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

Status:
Active, not recruiting
Trial end date:
2023-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Antibodies, Monoclonal
Docetaxel
Nivolumab
Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Disease progression experienced during or after one prior platinum containing doublet
chemotherapy

- Stage IIIb/IV or recurrent disease

- Male and Female ≥ 18 years of age

- Measurable disease per RECIST 1.1

- Performance Status ≤ 1

Exclusion Criteria:

- History of Carcinomatous meningitis

- Active Central nervous system (CNS) metastases

- History of auto immune diseases

- Prior treatment with Docetaxel

- Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or
checkpoint pathways