A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD L1 Selected, and Locally Advanced, Unresectable, or Metastatic Non Small Cell Lung Cancer
- Conditions
- ocally Advanced, Unresectable, or Metastatic Non Small Cell Lung CancerLung cancer
- Registration Number
- NL-OMON56010
- Lead Sponsor
- BeiGene Switzerland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
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 10^9/L
*Platelets >= 75 x 10^9/L *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 < 3 x ULN for patients
with Gilberts syndrome). d.AST and ALT <= 2.5 x ULN or < 5 x ULN if hepatic
metastases present. 10.Females of childbearing potential must be willing to use
a highly effective method of birth control for the duration of the study, and
for >= 120 days after the last dose of study drug, and must have a negative
urine or serum pregnancy test <= 7 days before randomization. 11.Nonsterile
males must be willing to use a highly effective method of birth control for the
duration of the study and for >= 120 days after the last dose of study drug. •A
sterile male is defined as one for whom azoospermia has been previously
demonstrated in a semen sample examination as definitive evidence of
infertility. •Males with known low sperm counts (consistent with
subfertility) are not to be considered sterile for purposes of this study.
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, or 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 human immunodeficiency virus (HIV)
infection, 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
t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary:<br /><br>• PFS as assessed by investigators (time from the date of randomization to the<br /><br>date of the first objectively documented tumor progression per RECIST v1.1, or<br /><br>death, whichever occurs first) in the ITT Analysis Set of Arm A (ociperlimab in<br /><br>combination with tislelizumab) and Arm B (pembrolizumab followed by placebo)<br /><br>• OS (time from the date of randomization to the date of death due to any<br /><br>cause) in the ITT Analysis Set of Arm A (ociperlimab in combination with<br /><br>tislelizumab) and Arm B (pembrolizumab followed by placebo) </p><br>
- Secondary Outcome Measures
Name Time Method