Phase 3
Completed N=363
A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
Source: ClinicalTrials.gov NCT02713867 ↗Enrolled (actual)
363
Serious AEs
37.2%
Results posted
Jun 2020
Primary outcomePrimary: Progression Free Survival Rate (PFSR) at 6 Months — 0.76; 0.79 Proportion of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival Rate (PFSR) at 6 Months |
0.76; 0.79 | — |
| PRIMARY Progression Free Survival Rate (PFSR) at 12 Months |
0.53; 0.55 | — |
| SECONDARY Progression Free Survival Rate (PFSR) at 24 Months |
0.34; 0.35 | — |
| SECONDARY Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months |
0.50; 0.42; 0.54; 0.60 | — |
| SECONDARY Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months |
0.63; 0.66; 0.47; 0.48 | — |
| SECONDARY Overall Survival (OS) Rate at 12 Months |
0.851; 0.908 | — |
| SECONDARY Overall Survival (OS) Rate up to 60 Months |
0.82; 0.88; 0.62; 0.70; 0.49; 0.57 | — |
| SECONDARY Overall Survival Rate by Histology at 12 Months |
0.74; 0.80; 0.86; 0.92 | — |
| SECONDARY Overall Survival Rate by Response Criteria at 12 Months |
0.90; 0.93; 0.78; 0.85 | — |
| SECONDARY Percentage of Participants With an Adverse Events (AEs) |
91.6; 97.8 | — |
| SECONDARY Percentage of Participants With an Serious Adverse Events (SAEs) |
34.8; 39.4 | — |
| SECONDARY Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC) |
19.1; 17.8 | — |
| SECONDARY Percentage of Participants With an Immune Mediated Adverse Events (IMAEs) |
3.4; 5.0; 0.0; 1.7; 3.4; 3.3 | — |
| SECONDARY Percentage of Participants With an Select Adverse Events |
18.5; 25.0; 2.2; 10.0; 6.7; 5.0 | — |
| SECONDARY Percentage of Participants With an Event of Special Interest (ESI) |
1.1; 2.8; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Experienced Death |
49.4; 43.9 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
1; 1; 1; 0; 1; 2 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy
- Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)
- Measurable disease before start of pre-study nivolumab treatment
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
Exclusion Criteria
- Carcinomatous meningitis
- Untreated, symptomatic Central nervous system (CNS) metastases
- Symptomatic interstitial lung disease
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02713867). 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.