Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
BeiGene, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments. 2.Age = 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place). 3.Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic nonsquamous or squamous NSCLC. 4.No prior systemic treatment for metastatic NSCLC. 5.Agreement to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or approximately 6 to 15 freshly cut unstained slides) or fresh biopsy (if archival tissue is not available) for central evaluation of PD-L1 levels and retrospective analysis of other biomarkers. 6.Tumors with PD-L1 expressed in = 50% tumor cells as determined centrally (or locally in the US sites). 7.At least 1 measurable lesion as defined per RECIST v1.1. 8.ECOG Performance Status = 1. 9.Adequate organ function as indicated by the following laboratory values during screening: a.Patients must not have required blood transfusion or growth factor support = 14 days before sample collection at screening for the following: -Absolute neutrophil count (ANC) = 1.5 x 109/L -Platelets = 75 x 109/L or 100 x 109/L in chemotherapy combination studies -Hemoglobin = 90 g/L b.Serum creatinine = 1.5 x upper limit of normal (ULN) or estimated Glomerular Filtration Rate = 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 8). Note: for France only: Serum creatinine = 1.5 x ULN and estimated glomerular filtration rate or estimated creatinine clearance = 60 mL/min/1.73 m2 by CKD-EPI and Cockcroft and Gault equations, respectively (Appendix 8). c.Serum total bilirubin = 1.5 x ULN (total bilirubin must be =65 years) yes F.1.3.1 Number of subjects for this age range 165
Exclusion criteria
Exclusion criteria: 1.Known mutation in a. EGFR gene b. ALK fusion oncogene c. BRAF V600E d. ROS1 2.Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3.Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Note:Patients with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following: -Brain imaging at screening shows no evidence of interim progression, patient is clinically stable for at least 2 weeks and without evidence of new brain metastases. -Measurable and/or evaluable disease outside the CNS. -No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 3 days before randomization; anticonvulsants at a stable dose are allowed. -No stereotactic radiation or whole-brain radiation within 14 days before randomization. 4.Active autoimmune diseases or history of autoimmune diseases that may relapse. 5.Any active malignancy = 5 years before randomization except for the specific cancer under investigation in this study, those with a negligible risk of metastasis or death, and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix or breast). 6.Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone[in Japan, prednisolone] or equivalent) or other immunosuppressive medication = 14 days before randomization. 7.Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or = Grade 3 hypoalbuminemia = 14 days before randomization. 8.Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention). Patients with symptomatic pleural effusion are excluded unless the patient undergoes a therapeutic thoracentesis or has had pleurodesis (more than 2 weeks prior) and has subsequently stable effusions. 9.History of interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, etc. All patients must undergo an assessment of pulmonary function at Screening 10.Infection (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization, or patients who tested positive for COVID-19 antigen by a licensed test during screening. 11.Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA > 500 IU/mL (or>2500 copies/mL) at screening. 12.Patients with active hepatitis C. 13.Known history of HIV or if HIV status is unknown, positive HIV test at screening. 14.Any major surgical procedure = 28 days before randomization. Patients must have recovered adequately from the toxicity and/or complications from the intervention before randomization. 15.Prior allogeneic stem cell transplantation or organ transplantation. 16.Any of the following cardiovascular risk factors: a.Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, = 28 days before randomization. b.Symptomatic pulmonary embolism = 28 days before randomization. c.Any history of acute myocardial infarction = 6 months before randomizatio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the Intent-to-Treat (ITT) Analysis Set as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) • To compare overall survival (OS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set;Secondary Objective: •To compare PFS between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set as assessed by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 •To compare the overall response rate (ORR) and duration of response (DOR) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set as assessed by investigators according to RECIST v1.1 •To compare health-related quality of life (HRQoL) and time to deterioration (TTD) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set •To further investigate the safety and tolerability of ociperlimab in combination with tislelizumab;Primary end point(s): • PFS as assessed by investigators (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) in the ITT Analysis Set of Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) • OS (time from the date of randomization to the date of death due to any cause) in the ITT Analysis Set of Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo);Timepoint(s) of evaluation of this end point: approximately 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PFS as assessed by the BIRC in Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) • ORR as assessed by investigators (proportion of patients with a documented, confirmed complete response [CR] or partial response [PR] per RECIST v1.1) and DOR as assessed by investigators (time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first) in Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) • HRQoL as assessed via patient-reported outcomes (PRO) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), its lung cancer module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13), and the 5-Level EuroQol 5-Dimension (EQ-5D-5L) questionnaire in Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo). PRO endpoints include the EORTC QLQC30's global health status/QoL (GHS), physical function and fatigue scales, and the QLQ-LC13's index score, dyspnea, coughing, hemoptysis and pain in chest, pain in arms/shoulders and peripheral neuropathy scales • TTD, defined as time from randomization to the first occurrence of worsening scores (10-point change, to be defined in the Statistical Analysis Plan [SAP] if otherwise) for 2 consecutive assessments or 1 assessment followed by death from any cause before the next scheduled data collection • The incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) in Arm A (BGB-A1217 in combination with tislelizumab);Timepoint(s) of evaluation of this end point: approximately 4 years | — |
Countries
Australia, China, France, Georgia, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Taiwan, Thailand, Türkiye, Ukraine, United States
Contacts
Public ContactBeiGene Clinical Support
BeiGene, Inc.
Outcome results
None listed