Phase 3
Completed N=504
Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT02613507 ↗Enrolled (actual)
504
Serious AEs
51.8%
Results posted
Feb 2019
Primary outcomePrimary: Median Overall Survival — 11.99; 9.63 Months — p=0.0006
◆ Published Evidence
Highly cited
357citations · ~51 / year
Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial.
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.
Linked Publications (2)
-
Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial.
-
Economic Evaluation of Nivolumab Versus Docetaxel for the Treatment of Advanced Squamous and Non-squamous Non-small Cell Lung Cancer After Prior Chemotherapy in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Overall Survival |
11.99; 9.63 | 0.0006 sig |
| PRIMARY Overall Survival Rate |
72.4; 64.8; 49.7; 38.8 | — |
| SECONDARY Objective Response Rate (ORR) |
17.5; 4.2; 21.1; 1.5; 15.1; 6.1 | — |
| SECONDARY Overall Survival (OS) in Subpopulations |
11.99; 7.89; 11.37; 10.25; 15.57; 16.30 | — |
| SECONDARY Progression Free Survival (PFS) |
2.79; 2.76; 2.92; 2.66; 2.60; 2.83 | — |
| SECONDARY Progression Free Survival Rate |
29.3; 24.8 | — |
| SECONDARY Time to Treatment Failure (TTF) |
2.60; 1.51 | — |
| SECONDARY Number of Participants Experiencing Treatment-Related Adverse Events (AEs) |
220; 131 | — |
| SECONDARY Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs) |
34; 25 | — |
| SECONDARY Disease Related Symptom Deterioration Rate by Week 12 and Week 24 |
29.9; 40.4; 34.6; 42.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02613507) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.