EUCTR2019-003454-83-NL进行中（未招募）1 期
Ipilimumab plus Nivolumab and ChemoRadiotherapy followed by Surgery in patients with resectable and borderline resectable T3-4N0-1 NSCLC - INCREASE
Amsterdam UMC, VU University Medical Center0 个研究点目标入组 29 人开始时间: 2019年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
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
- •1.Histologically confirmed NSCLC, a histological biopsy is mandatory
- •2.T3-4, N0-1 tumors based on size or upon ingrowth into the thoracic wall, mediastinum, vertebra or diaphragm
- •3.Patients that are irresectable upfront, but expected to be resectable after chemoradiotherapy induction, as per multidisciplinary tumor board evaluation
- •4.Be willing and able to provide written informed consent for the trial.
- •5.Be above 18 years of age on day of signing informed consent.
- •6.Have measurable disease based on RECIST 1.1. 9.
- •7.Have a performance status of 0-1 on the ECOG Performance Scale.
- •8.Demonstrate adequate organ function.
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •1.Known oncogenic drivers such as activating EGFR or BRAF mutations or ALK or ROS1 gene rearrangements
- •2.Prior surgery and/or radiotherapy on the ipsilateral thorax
- •3.Patients deemed inoperable
- •4.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •5.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.
- •6.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.
- •7.Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •8.Active infection requiring systemic therapy.
- •9.Ahistory of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •10.Active Hepatitis B or C.
- •11.Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •12.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.
- •13.Patient is pregnant or breastfeeding, or expecting to conceive 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.
- •A Woman of Childbearing Potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
- •WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of nivolumab. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of nivolumab.
- •These durations have been calculated using the upper limit of the half-life for nivolumab (~25 days) and are based on the recommendation that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days after the last dose of nivolumab. Females should not breastfeed while receiving nivolumab and for any subsequent protocol-specified period. Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. Local laws and regulations may require use of alternative and/or additional contraception methods. One of the highly effective methods of contraception listed below is required during study duration and until the end of relevant sys
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