Non-Small Cell Lung Cancer
Conditions
Brief summary
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Detailed description
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Interventions
DRUGNivolumab
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * 1\) Stage IV or recurrent non-Small cell lung cancer * 2\) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * 3\) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
Exclusion criteria
* 1\) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy * 2\) Active, known or suspected autoimmune disease or HIV infection * 3\) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) * 4\) Untreated Central Nervous System metastases Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events | Approximately 3 months |
| Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events | Approximately 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 24 months |
| Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 24 months |
| Overall survival (OS) as defined as the time from first dosing to the date of death | Up to 5 years |
| Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 24 months |
Countries
Argentina, Canada, Germany, Peru, United States
Outcome results
None listed