Phase 2
N=811
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02409368 ↗Enrolled (actual)
811
Serious AEs
70.8%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events — 1; 7; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events |
1; 7; 0; 1; 10; 0 | — |
| SECONDARY Number of Participants With High Grade Select Adverse Events |
2; 7; 0; 1; 11; 0 | — |
| SECONDARY Median Time to Onset of Any Grade Select Adverse Events |
12.79; 10.14; 19.86; 11.71; 8.86; 6.00 | — |
| SECONDARY Median Time to Resolution of Any Grade Select Adverse Events |
NA; 169.43; NA; 2.86; 2.00; 2.00 | — |
| SECONDARY Overall Survival |
12.1; 10.3; 5.2 | — |
| SECONDARY Objective Response Rate (ORR) |
8.0; 11.0; 1.6 | — |
Summary
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- ECOG Status: PS 0-1 & PS 2
- Subjects with histologically or cytologically-documented SqNSCLC
- Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
- Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
- Subjects with treated or asymptomatic CNS metastases
- Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
- Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
- Males and Females, ages 18 or older
Exclusion Criteria
- Subjects with untreated, symptomatic CNS metastases
- Subjects with carcinomatous meningitis
- Subjects with active, known or suspected autoimmune disease.
- Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
Data sourced from ClinicalTrials.gov (NCT02409368). 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.