NL-OMON55382已完成2 期
An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in combination with Ipilimumab in Subjects with Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC) - CA209-592
Bristol-Myers Squibb0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- •Male and female patients over the age of 18 with ECOG status of 0-1
- •Patients with histologically confirmed Stage IV or recurrent NSCLC squamous
- •or non-squamous histology, with no prior systemic anticancer therapy (including
- •EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic
- •* - Prior adjuvant or neoadjuvant chemotherapy is permitted as long as the last
- •administration of the prior regimen occurred at least 6 months prior to
- •enrollment.
- •* - Prior definitive chemoradiation for locally advanced disease is also
- •permitted as long as the last administration of chemotherapy or radiotherapy
- •(which ever was given last) occurred at least 6 months prior to enrollment.
- •Measurable disease by CT or MRI per RECIST 1.1.
- •Patients must have tissue submitted during screening (fresh biopsy or achival
- •sample not older than 3 months) for biomarker testing. Treatment may start
- •before test results are received.
- •Women of childbearing potential must not be breastfeeding and must have a
- •negative serum or urine pregnancy test within 24 hours prior to start of study
- •treatment. This test will be repeated every 4 weeks during the study. Patients
- •must follow the contraception requirements while enrolled in the study.
排除标准
- •Patients previously treated with drugs targeting T-cell co-stimulation or
- •checkpoint pathways
- •Patients with known EGFR mutations or ALK translocations sensitive to
- •available targeted inhibitor therapy
- •Patients with untreated central nervous system metastases
- •Patients with an active, known or suspected autoimmune disease. Patients with
- •type I diabetes mellitus, hypothyroidism only requiring hormone replacement,
- •skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring
- •systemic treatment, or conditions not expected to recur in the absence of an
- •external trigger are permitted to enroll.
- •Patients with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days of enrollment.
- •Patients with interstitial lung disease or who are incarcerated or
- •temporarily detained for psychiatris of physical illness.
研究者
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