Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Korábbi kezelés

• Prior immune checkpoint inhibitor therapy
• Systemic chronic steroid therapy (>10mg/d prednisone or equivalent)

Más betegség

• Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• 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.
• Clinically significant infection, as assessed by the investigator
• 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

Laborértékek

• Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)
• 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

Egyéb

• Active brain metastases
• Pregnant or breast-feeding (lactating) women

• Adult patient aged ≥ 18 years
• Written informed consent
• Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC
• 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