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临床试验/EUCTR2017-000358-20-FR
EUCTR2017-000358-20-FR进行中（未招募）1 期

Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer

G1 Therapeutics0 个研究点目标入组 100 人开始时间: 2017年9月8日最近更新:
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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

  • •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 and at baseline. Females must be either postmenopausal, surgically sterile, or using an acceptable method of contraception. Menopause is defined as 12 months of amenorrhea in a woman over the age of 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone (FSH) level > 40 mIU/mL to confirm menopause. Females treated with hormone replacement therapy (HRT) are likely to have artificially suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH level. If the serum FSH level is > 40 mIU/mL at any time during the washout period, the woman can be considered postmenopausal. Acceptable surgical sterilization techniques are
  • •hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing, and bilateral oophorectomy, with surgery at least 2 months prior to dosing. Acceptable methods of contraception are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 3 months prior to dosing), a vasectomized partner, and a barrier method (condom or diaphragm) during the study and for 6
  • •months after discontinuation of treatment
  • •b. For males: Patients with female partner of childbearing potential must agree to use a highly effective form of birth control, which entails the use of oral, injected, or implanted hormonal methods of contraception or an intrauterine device/system by the female partner, in combination with a barrier method (eg, condom, diaphragm, cervical cap) during the study and for 6 months after discontinuation of treatment, and will also refrain from sperm donation for 6 months following completion of the study
  • •14. Able to understand and sign an informed consent
  • •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 25
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 75

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. Hypersensitivity to carboplatin or

研究者

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