A PHASE IIIB, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) IN COMBINATION WITH CARBOPLATIN PLUS ETOPOSIDE TO INVESTIGATE SAFETY AND EFFICACY IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER -

ROCHE SPA0 个研究点目标入组 150 人开始时间: 2021年6月17日最近更新: 2021年8月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ROCHE SPA
入组人数: 150

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Signed Informed Consent Form
•- Age > 18 years at time of signing Informed Consent Form
•- Ability to comply with the study protocol, in the investigator's judgment
•- Histologically or cytologically confirmed ES-SCLC per the Veterans Administration Lung Study Group (VALG) staging system
•- Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease
•- Eastern Cooperative Oncology Group (ECOG) performance status (PS) from 0 to 2
•- Life expectancy > 12 weeks
•- No prior systemic treatment for ES-SCLC
•- Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6
•months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of ES-SCLC
•- Patients where thoracic radiotherapy (RT) is clinically indicated could be enrolled providing they receive RT between the completion of induction phase and the beginning of maintenance phase
•- Patients with Paraneoplastic syndromes can be enrolled if an autoimmune origin can be excluded
•- Adequate hematologic and end organ function
•Negative human immunodeficiency virus (HIV) test at screening- Negative hepatitis B surface antigen (HBsAg) test at screening
•- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
•The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
•- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
•The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
•- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraception
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm,
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

排除标准

•Symptomatic or actively progressing central nervous system (CNS) metastases
•- History of leptomeningeal disease
•- Uncontrolled tumor-related pain
•- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
•- Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium >12 mg/dL or corrected calcium >ULN)
•- Active or history of autoimmune disease or immune deficiency
•- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
•obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
•pneumonitis on screening chest computerized tomography (CT) scan
•History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
•- Active tuberculosis
•- Significant cardiovascular disease, (such as New York Heart Association Class II or
•greater cardiac disease, myocardial infarction, or cerebrovascular accident) within
•3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
•Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of
•study treatment, or anticipation of need for a major surgical procedure during the study
•- History of malignancy other than SCLC within 5 years prior to screening, with exceptions
•- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
•- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
•Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
•- Prior allogeneic stem cell or solid organ transplantation
•- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
•- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
•- Current treatment with anti-viral therapy for HBV
•- 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¿CTLA-4, anti¿PD-1, and anti¿PD-L1 therapeutic antibodies
•- Treatment with systemic immunostimulatory agents (including, but not limited to,
•interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives
•(whichever is longer) prior to initiation of study treatment
•- Treatment with systemic immunosuppressive medication (including, but not limited to,
•corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
•anti -TNF- agents) within 2 weeks prior to initiation of study treatment, or anticipation
•of need for systemic immunosuppressive medication during study treatment, with exceptions
•History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
•or fusion proteins
•- Known hypersensitivity to Chinese hamster ovary cell products or to any component
•of the atezolizumab formulation
•- Known allergy or hypersensitivity to car

研究者

发起方

ROCHE SPA

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