Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Servier Bio-Innovation LLC
With
Institut de Recherches Internationales Servier
Regeneron Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patient aged ≥ 18 years
Written informed consent
You may not be if
No prior systemic treatment for locally advanced or metastatic NSCLC
High tumor cell PD-L1 expression \[Tumor Proportion Score (TPS) ≥50%\] based on documented status as determined by an approved test
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease as determined by RECIST v1.1
Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)
Prior immune checkpoint inhibitor therapy
Active brain metastases
Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll
Active, known or suspected autoimmune disease or immune deficiency
History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients
History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2
History of inflammatory bowel disease or colitis ≥ grade 2
History of hemophagocytic lymphohistiocytosis.
Systemic chronic steroid therapy (\>10mg/d prednisone or equivalent)
Clinically significant infection, as assessed by the investigator
Pregnant or breast-feeding (lactating) women
Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant)
Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study
