Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
- Trial number:
-
NCT04262856
- Trial phase:
- 2
- Study type:
- Immunotherapy, Targeted therapy, Biomarker
- Overall status:
- Active, not recruiting
Study start date
Scientific title
Summary
Male or female participants; age ≥ 18 yearsHistologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Must have at least 1 measurable lesion per RECIST v1.1 Adequate organ and marrow function
Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption) History of trauma or major surgery within 28 days prior to the first dose of IMP Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer