Phase 2
Completed N=341
A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT02574078 ↗Enrolled (actual)
341
Serious AEs
45.6%
Results posted
May 2021
Primary outcomePrimary: Progression-Free Survival (PFS), Groups A-D Only — 15.0; 6.7; 6.0; 5.9 Months — p=0.5050
Summary
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS), Groups A-D Only |
15.0; 6.7; 6.0; 5.9; 8.1; 5.0 | 0.5050 |
| PRIMARY Overall Survival (OS), Groups A-C Only |
20.0; 30.8; 18.1; 28.9; 17.4; 18.4 | 0.9951 |
| PRIMARY Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only |
38.5 | — |
| SECONDARY Duration of Response (DOR), Groups A-D Only |
12.780; NA; 17.084; 12.912; 8.542; 14.982 | — |
| SECONDARY Objective Response Rate (ORR), Groups A-E |
23.1; 16.7; 12.5; 29.4; 21.2; 3.1 | — |
| SECONDARY Overall Survival (OS), Group D Only |
NA; 34.8 | 0.2862 |
| SECONDARY Progression-Free Survival (PFS), Group E Only |
9.63 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Histologically confirmed locally advanced or stage IV NSCLC
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
- Tumor tissue sections must be available for biomarker evaluation
Exclusion Criteria
- Untreated or active/progressing Central Nervous system (CNS) metastases
- Active, known or suspected autoimmune disease
- Known history of testing positive for HIV or AIDS
- Active or chronic infection of hepatitis B virus or hepatitis C
Data sourced from ClinicalTrials.gov (NCT02574078). 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.