A PHASE III, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF TIRAGOLUMAB, AN ANTI-TIGIT ANTIBODY, IN COMBINATION WITH ATEZOLIZUMAB COMPARED WITH PLACEBO IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PD-L1-SELECTED NON-SMALL CELL LUNG CANCER.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 500 人开始时间: 2020年5月10日最近更新: 2020年11月16日

适应症

试验速览

暂无简介。

•- Age >= 18 years
•- Eastern Cooperative Oncology Group Performance Status of 0 or 1
•- Histologically or cytologically documented locally advanced or recurrent NSCLC
•- No prior systemic treatment for metastatic NSCLC
•- Tumor PD-L1 expression as determined by PD-L1 IHC assay of archival tumor tissue
•- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
•- Adequate hematologic and end-organ function.
•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 254
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 246

•- Known to have a mutation in the EGFR gene or an ALK fusion oncogene
•- Symptomatic, untreated, or actively progressing central nervous system metastases
•- Active or history of autoimmune disease or immune deficiency
•- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
•- Significant cardiovascular disease
•- History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
•- Severe infection within 4 weeks prior to initiation of study treatment
•- Current treatment with anti-viral therapy for HBV or HCV
•- Treatment with investigational therapy within 28 days prior to initiation of study treatment
•- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
•- Treatment with systemic immunostimulatory agents or anticipation of need for systemic immunosuppressive medication during study treatment prior to initiation of study treatment.

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