Non-small Cell Lung Cancer, NSCLC
Conditions
Keywords
Locally Advanced, Unresectable, Metastatic, Tislelizumab, BGB-A317, Ociperlimab, BGB-A1217, Pembrolizumab, Anti-TIGIT
Brief summary
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.
Interventions
DRUGTislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
DRUGOciperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
DRUGPembrolizumab
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
DRUGPlacebo
Placebo infusions will consist of a sterile, normal saline solution.
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC. 2. No prior systemic treatment for metastatic NSCLC. 3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). 4. Tumors with PD-L1 expressed in ≥ 50% tumor cells. 5. At least 1 measurable lesion as defined per RECIST v1.1. 6. ECOG Performance Status ≤ 1. Key
Exclusion criteria
1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 58 months | OS will be defined as the time from the date of randomization to the date of death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) As Assessed By Investigators | Up to approximately 58 months | ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1. |
| Duration Of Response (DOR) As Assessed By Investigators | Up to approximately 58 months | 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. |
| Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) | Within 7 days after permanent treatment discontinuation | 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. |
| Progression-free Survival (PFS) As Assessed By Investigators | Up to approximately 58 months | 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. |
| HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire | Within 7 days after permanent treatment discontinuation | 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 To Deterioration (TTD) | Within 7 days after permanent treatment discontinuation | 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. |
| Number Of Participants Experiencing Adverse Events (AEs) | 90 days (±14) after last dose | 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). |
| 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. | Within 7 days after permanent treatment discontinuation | 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. |
Countries
Argentina, Australia, Brazil, China, France, Georgia, Germany, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Outcome results
None listed