EUCTR2017-000358-20-BG进行中（未招募）1 期
Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or WithoutTrilaciclib (G1T28) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •For a patient to be eligible for participation in this study, all of the following criteria must
- •1. Age = 18 years
- •2. Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably
- •including the presence of neuroendocrine features by immunohistochemistry
- •3. Extensive-stage SCLC
- •4. At least 1 target lesion that is measurable by RECIST v1.1 (Eisenhauer 2009)
- •5. Hemoglobin = 9.0 g/dL
- •6. Absolute neutrophil count (ANC) = 1.5 × 109/L
- •7. Platelet count = 100 × 109/L
- •8. Creatinine = 1.5 mg/dL or glomerular filtration rate (GFR) of = 60 mL/minute
- •9. Total bilirubin = 1.5 × ULN; < 3 × ULN if the patient has documented Gilbert’s disease
- •10. AST and ALT = 2.5 × ULN; = 5 × ULN in the presence of liver metastases
- •11. ECOG performance status of 0 to 2
- •12. Predicted life expectancy of = 3 months
- •13. Contraception:
- •a. For females: All females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) test result at screening. Females must be either
- •postmenopausal, surgically sterile, or agree to use 2 forms of highly effective contraception during the study and for 6 months following discontinuation of study treatment
- •i. Postmenopausal is defined as (1) at least 60 years of age, (2) medically confirmed ovarian failure, or (3) younger than 60 years of age and have had cessation of regular
- •menses for at least 12 consecutive months with no alternative pathological or physiological cause, and/or serum levels of estradiol and follicle stimulating
- •hormone within the laboratory’s reference range for postmenopausal females
- •ii. Acceptable surgical sterilization techniques are complete or partial hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing, or bilateral
- •oophorectomy with surgery at least 2 months prior to dosing
- •iii. Highly effective methods of contraception are those that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly. These include the
- •1. Established use of oral, injected or implanted hormonal methods of contraception (stable dose at least 3 months prior to dosing)
- •2. Placement of an intrauterine device or intrauterine system
- •3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. Barrier
- •methods alone (without spermicide) are not acceptable methods. Likewise, spermicide alone is not an acceptable method
- •4. Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
- •5. True abstinence, when this is in line with the preferred and usual lifestyle of the subject.
- •Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and
- •withdrawal are not acceptable methods of contraception
- •b. For males: Males must be surgically sterile or have a female partner who is either postmenopausal, surgically sterile, or using 2 forms of highly effective contraception as noted above. Acceptable surgical sterilization techniques are vasectomy with surgery at least 6 months prior to dosing. Males must also refrain from sperm donation during the
- •study and for 6 months following discontinuation of treatment
- •14. Able to understand and sign an informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this ag
排除标准
- •A patient will not be eligible for participation in this study if any of the following criteria
- •1. Limited-stage SCLC
- •2. Prior chemotherapy for limited or extensive-stage SCLC
- •3. Prior treatment with immunotherapies including but not limited to cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies (such as anti-PD-1, anti-PD-L1, CTLA4 therapeutic antibodies)
- •4. Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids
- •5. Malignancies other than SCLC within 3 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- •6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan (history of radiation pneumonitis in the radiation field [fibrosis] is permitted)
- •7. Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Exceptions include vitiligo, controlled asthma, type I diabetes, Graves’ disease, Hashimoto’s disease, or with medical monitor approval. Stable replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) for well-controlled disease is not
- •considered a form of systemic treatment.
- •8. Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure
- •(Class III or IV as defined by the New York Heart Association [NYHA] functional classification system)
- •9. Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
- •10. Serious active infection at the time of enrollment
- •11. Psychiatric illness/social situations that would limit study compliance
- •12. Other uncontrolled serious chronic disease or conditions that in the investigator’s opinion
- •could affect compliance or follow-up in the protocol
- •13. Known human immunodeficiency virus (HIV), known active Hepatitis B (eg, HBsAg
- •reactive or HBV DNA detected) or Hepatitis C (eg, HCV RNA [qualitative] is detected)
- •14. Radiotherapy to any site within 2 weeks prior to enrollment
- •15. Receipt of any investigational medication within 4 weeks prior to enrollment
- •16. Administration of a live attenuated vaccine within 4 weeks before enrollment or anticipation that such a live attenuated vaccine will be required during the study
- •17. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (eg, FluMist) within 4 weeks prior to enrollment, at any time during the study, and at least 5 months after the last dose of atezolizumab
- •18. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide,
- •and anti-tumor necrosis factor [TNF] agents) within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •19. Hypersensitivity to any of the components of the formulation of etoposide or etoposide phosphate
- •20. Hypersens
研究者
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