NL-OMON48462已完成2 期
Ipilimumab plus Nivolumab and ChemoRadiotherapy followed by Surgery in patients with resectable and borderline resectable T3-4N0-1 NSCLC - INCREASE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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.
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
- •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 a
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