NL-OMON54614招募中不适用
18F-PD-L1 PET/CT to predict response to nivolumab in patients with NSCLC - 18F-PD-L1 PET/CT in nivolumab treated patients with NSCLC
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Have a histologically or cytologically confirmed diagnosis of stage IV, EGFR
- •WT and EML4-ALK fusion negative NSCLC. Mutational testing is not necessary in
- •patients with squamous NSCLC.
- •2. Eligible for first line chemo-immunotherapy, first line nivolumab +
- •ipilimumab or 2nd line and beyond PD-(L)1 immunotherapy monotherapy .
- •3. Be willing and able to provide written informed consent for the trial.
- •4. Be >= 18 years of age on day of signing informed consent.
- •5. Have measurable disease based on RECIST 1.1.
- •6. Must provide tissue from a histological biopsy of a tumor lesion that is not
- •radiated prior to biopsy and obtained after the last line of systemic therapy,
- •to determine the actual PD-L1 status.
- •7. Have a performance status of 0-1 on the ECOG Performance Scale.
- •8. Demonstrate adequate hematologic and organ function, defined by the
- •following laboratory results. All screening laboratory tests should be
- •performed within 30 days prior to day 1 (PET imaging):
- •- Absolute neutrophil count (ANC) >= 1500 cells/µL
- •- WBC count >= 2000 cells/µL
- •- Platelet count >= 100.000/µL
- •- Hemoglobin >= 5.6 mmol/L
- •- AST and ALT <= 3 x ULN (<= 5 x ULN if liver metastases are present)
- •- Serum bilirubin <= 1.5 x ULN (except subjects with known Gilbert disease, who
- •can have total bilirubin < 3.0 mg/dL)
- •- Serum Creatinine <= 1.5 x ULN OR measured of calculated creatinine clearance
- •(GFR can also be used in place of creatinine or CrCl) >= 40 mL/min for subject
- •with creatinine levels > 1.5 x ULN.
排除标准
- •1. Subjects with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days prior to day 1 (PET imaging).
- •Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily
- •prednisone equivalent, are permitted in the absence of active autoimmune
- •2. Has a known additional malignancy that is progressing or requires active
- •treatment. Exceptions include basal cell carcinoma of the skin, squamous cell
- •carcinoma of the skin, or in situ cervical cancer that has undergone
- •potentially curative therapy.
- •3. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous
- •meningitis.
- •- Note: Subjects with asymptomatic CNS metastases are allowed to enter the
- •- Note: Subjects with previously treated brain metastases may participate
- •provided they are clinically stable and not using steroids with > 10 mg daily
- •prednisone equivalent for at least 7 days prior to trial treatment.
- •4. Has an active autoimmune disease requiring systemic steroid treatment within
- •the past 3 months or a documented history of clinically severe autoimmune
- •disease, or a syndrome that requires systemic steroids.
- •5. Has evidence of interstitial lung disease or active, non-infectious
- •pneumonitis.
- •6. Has an active infection requiring systemic therapy.
- •7. Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the trial, interfere with the
- •subject*s participation for the full duration of the trial, or is not in the
- •best interest of the subject to participate, in the opinion of the treating
- •investigator.
- •8. Has known psychiatric or substance abuse disorders that would interfere with
- •cooperation with the requirements of the trial.
- •9. Is pregnant or breastfeeding, or expecting to conceive or father children
- •within the projected duration of the trial, starting with the pre-screening or
- •screening visit through 23 weeks after the last dose of trial treatment.
- •10. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2,
- •anti-CTLA-4 antibody, or any other antibody or drug specifically targeting
- •T-cell co-stimulation or immune checkpoint pathways.
- •11. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2
- •antibodies).
- •12. Has known active Hepatitis B or C.
研究者
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