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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Specified dose on specified days
Specified dose on specified days
Local Institution
San Francisco, California, United States
Local Institution
Lincoln, Nebraska, United States
Local Institution
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
Time frame: Approximately 3 months
Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
Time frame: Approximately 3 months
Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 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)
Time frame: Up to 24 months
Overall survival (OS) as defined as the time from first dosing to the date of death
Time frame: Up to 5 years
Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 24 months
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Hackensack, New Jersey, United States
Local Institution
Columbus, Ohio, United States
Local Institution
Lancaster, Pennsylvania, United States
Local Institution
Langhorne, Pennsylvania, United States
Local Institution
Sayre, Pennsylvania, United States
Local Institution
Charleston, South Carolina, United States
Local Institution
St. George, Utah, United States
Local Institution
Viedma, Río Negro Province, Argentina
...and 7 more locations