A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination with Carboplatin, Etoposide and Atezolizumab in Induction and with Atezolizumab in Maintenance Phase

ovartis Pharma AG0 个研究点目标入组 200 人开始时间: 2021年12月27日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Key Inclusion Criteria:
•Participant is = 18 years on the day of signing informed consent form
•Histologically or cytologically confirmed ES-SCLC
•Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan
•SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake equal or higher than the liver uptake (uptake intensity score 2 or above in the visual uptake scoring scale) in at least one target or non-target lesion
•No prior systemic treatment for ES-SCLC (except the first cycle of
•chemotherapy with or without atezolizumab of the induction period)
•Provision of tumor tissue to support exploratory biomarker analysis
•Life expectancy of >=6 months
•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 87
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 113

•Key exclusion Criteria:
•Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
•Active leptomeningeal disease or uncontrolled, untreated brain metastasis
•Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 2 Day 1
•History of current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
•Known hypersensitivity to the active substances or any of the excipients of the study drugs
•Concurrent participation in another therapeutic clinical study

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