Phase 2
Completed N=129
Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT03090737 ↗Enrolled (actual)
129
Serious AEs
43.4%
Results posted
Mar 2022
Primary outcomePrimary: The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE) — 3; 0 Participants
Summary
A study to evaluate the safety of Nivolumab in participants with advanced or metastatic non-small cell lung cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE) |
3; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
3.68 | — |
| SECONDARY Objective Response Rate (ORR) |
17.1 | — |
| SECONDARY Overall Survival (OS) |
10.58 | — |
| SECONDARY Duration of Response (DOR) |
35.45 | — |
Eligibility Criteria
Inclusion Criteria
- Non small cell lung cancer (Squamous or non-squamous)
- At least one prior anti-cancer therapy that did not work
- ECOG Performance Scale 0-1
Exclusion Criteria
- Cancer that has spread to the brain or leptomeninges unless there is no evidence of progression by MRI for 8 weeks after treatment is complete and within 28 days before first dose of study drug
- Active, known or suspected autoimmune disease or infection
- Prior immuno-oncology therapy
- Corticosteroids within 2 weeks of study drug administration
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03090737). 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.