A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN VERSUS PEMBROLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER. - NA

F. HOFFMANN - LA ROCHE LTD.0 个研究点目标入组 200 人开始时间: 2021年5月20日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC
•No prior systemic treatment for metastatic non-squamous NSCLC
•Known tumor PD-L1 status
•Measurable disease, as defined by RECIST v1.1
•Life expectancy >= 12 weeks
•Adequate hematologic and end-organ function
•Negative HIV test at screening
•Serology test negative for active hepatitis B virus or active hepatitis C virus at screening
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Patients with NSCLC which harbors a mutation in the EGFR gene or an ALK fusion oncogene
•Symptomatic, untreated, or actively progressing central nervous system (CNS) 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 peumonitis
•History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
•Severe infection within 4 weeks prior to initiation of study treatment
•Treatment with investigational therapy within 28 days prior to initiation of study treatment
•Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
•Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
•Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.

发起方