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 560 人开始时间: 2020年4月15日最近更新: 2024年9月2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 not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy, or metastatic Stage IV NSCLC
•- No prior systemic treatment for metastatic NSCLC
•- Tumor PD-L1 expression as determined by PD-L1 IHC assay TPS >= 50% as determined by 22C3 pharmaDx assay TC3 or IC3 as determined by the VENTANA PD-L1 Assay (SP142), or TC >= 50% as determined by the investigational VENTANA PD-L1 CDx Assay (SP263) of tumor tissue
•- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
•- Adequate hematologic and end-organ function
•- For patients enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
•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 284
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 276

•- 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, with the exception of malignancies with a negligible risk of metastasis or death treated with curative intent
•- Severe infection within 4 weeks prior to initiation of study treatment
•- Positive test result for human immunodeficiency virus (HIV)
•- Active hepatitis B or hepatitis C infection
•- 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 within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.

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