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

Phase 1

• Conditions: Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable,or Metastatic Non-Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004985-21-PL
• Lead Sponsor: BeiGene, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-12
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

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
-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 (CKD-EPI) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 495
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 165

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 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 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 in

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified