This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
272
900 mg intravenously (IV) once every 3 weeks (Q3W)
200 mg IV Q3W
Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle
Progression-free Survival (PFS)
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Duration of Response (DOR)
DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Overall Survival (OS)
OS was defined as the time from randomization to the documented date of death for participants who died on or before the clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.
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75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle
100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle
75 mg/m², administered intravenously on Day 1 of each 21-day cycle
500 mg/m² administered intravenously on Day 1 of each 21-day cycle
Administered intravenously Q3W to match ociperlimab
Valkyrie Clinical Trials
Los Angeles, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
Rj Zuckerberg Cancer Center
New Hyde Park, New York, United States
North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)
New York, New York, United States
North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States
Ny Cancer and Blood Specialists
The Bronx, New York, United States
Xcancerdayton Physician Network
Dayton, Ohio, United States
Tennessee Cancer Specialist
Knoxville, Tennessee, United States
Texas Oncology Tyler Longview
Austin, Texas, United States
...and 54 more locations
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
The number of participants who experienced TEAEs and SAEs was reported. An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.
Time frame: From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 months)