The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
662
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
Overall Survival (OS)
OS will be defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 58 months
Progression-free Survival (PFS) As Assessed By Investigators
PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.
Time frame: Up to approximately 58 months
Overall Response Rate (ORR) As Assessed By Investigators
ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
Time frame: Up to approximately 58 months
Duration Of Response (DOR) As Assessed By Investigators
DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.
Time frame: Up to approximately 58 months
Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)
HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30. The EORTC QLQ-C30 (Version 3) consists of Global health status/QoL (score range from 0=very poor to 7=excellent), 5 functioning scales (physical, role, emotional, cognitive, social), 8 symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, constipation, diarrhea) and financial difficulties with scores ranging from 1 = "Not at all" to 4 = "Very much". For the global health status/QoL and functioning scales, higher scores indicate better outcomes and for symptom scales, lower scores indicate better outcomes.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo infusions will consist of a sterile, normal saline solution.
Providence Medical Foundation St Jude Heritage Healthcare
Fullerton, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
Ocala, Florida, United States
Advent Health Cancer Institute
Orlando, Florida, United States
Goshen Center For Cancer Care
Goshen, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University Medical Center New Orleans West Jefferson Medical Center
New Orleans, Louisiana, United States
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Centro Medical Austral
Buenos Aires, Argentina
...and 208 more locations
Time frame: Within 7 days after permanent treatment discontinuation
HRQoL: EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) HRQoL will be assessed via PRO using the EORTC QLQ-LC13.
QLQ-LC13 consists of 10 scales, scores ranging from 1 = "not at all" to 4 = "very much", and 2 questions regarding use of pain medication (yes/no) and if yes, did it help (1 = "not at all" to 4 = "very much"). In symptom scales, lower scores indicate better outcomes.
Time frame: Within 7 days after permanent treatment discontinuation
HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire
HRQoL will be assessed via PRO using the EQ-5D-5L. The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analog scale (VAS). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 0 to 100 scale, with 100 = "the best health you can imagine" and 0 = "'the worst health you can imagine". Lower scores in descriptive dimension indicate better HRQoL and higher VAS scores indicates better health state.
Time frame: Within 7 days after permanent treatment discontinuation
Time To Deterioration (TTD)
TTD will be analyzed using PRO scores, and will be defined as worsening scores of ≥10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause.
Time frame: Within 7 days after permanent treatment discontinuation
Number Of Participants Experiencing Adverse Events (AEs)
The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).
Time frame: 90 days (±14) after last dose