Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer (CheckMate 078)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Docetaxel; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02613507

2015-001893-16 (EudraCT Number)

CA209-078

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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504 participants in 2 patient groups

Arm A: Nivolumab

Experimental group

Description:

Nivolumab Intravenous infusion specified dose on specified days

Treatment:

Drug: Nivolumab

Arm B: Docetaxel

Active Comparator group

Description:

Docetaxel Intravenous infusion specified dose on specified days

Treatment:

Drug: Docetaxel