The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,021
Administered intravenously
Administered intravenously
Administered intravenously
Overall Survival (OS) in Participants With Positive Programmed Cell Death-Ligand 1 (PD-L1) Expression (≥1%Tumor Cells) and in all Randomized Participants.
OS is defined as the time from the date of randomization to the date of death from any cause.
Time frame: Up to 68 months
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from the date of randomization until disease progression (PD) or death from any cause, whichever comes first.
Time frame: Upt to 50 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.
Time frame: Up to 50 Months
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
DOR is defined as the time from the first response (CR or PR), to the first documented PD or death from any cause, whichever comes first.
Time frame: Up to 50 Months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 50 months plus 30 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 50 months plus 30 days
Time to First Symptom Deterioration in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Innovative Clinical Research Institute
Whittier, California, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, United States
Illinois Cancer Care
Peoria, Illinois, United States
Messino Cancer Centers
Asheville, North Carolina, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Hematology & Oncology Associates
Eugene, Oregon, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Texas Oncology - Austin
Austin, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Blacksburg, Virginia, United States
...and 176 more locations
The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \<symptom\> At All" to "Very severe \<symptom\>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.
Time frame: Baseline, Up to 50 Months