Phase 3
N=400
A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia
Lung Cancer · Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03195491 ↗Enrolled (actual)
400
Serious AEs
42.3%
Results posted
Jul 2024
Primary outcome: Primary: Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events — 2; 8; 5; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events |
2; 8; 5; 2; 7 | — |
| SECONDARY Number of HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events |
0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) |
375; 17 | — |
| SECONDARY Overall Survival (OS) |
14.16; 22.31; 14.65; 13.31; 19.25; 14.65 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.61; 2.04; 3.61; 2.33; 4.73; 2.37 | — |
| SECONDARY Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests |
16; 1; 5; 0; 4; 0 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events (SAEs) |
157; 12 | — |
| SECONDARY Objective Response Rate |
14.88; 17.65; 15.00; 18.38; 13.26; 6.32 | — |
| SECONDARY Duration of Tumor Response |
NA; 19.38; 19.38; 12.62; 19.61; 19.38 | — |
| SECONDARY Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests |
87; 1; 63; 0; 36; 1 | — |
| SECONDARY Time to Treatment Failure (TTF) |
2.23; 1.97; 2.10; 3.68; 1.94; 1.86 | — |
Summary
The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
- 1 to 2 prior systemic therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
- Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
- Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment
Exclusion Criteria
- Women with a positive pregnancy test at enrollment or prior to administration of study medication
- Participants with active central nervous system metastases
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
- Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
- Participants with carcinomatous meningitis
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03195491). 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.