EUCTR2017-004195-58-IT进行中（未招募）1 期
CAVE (Cetuximab-AVElumab) lung: A single arm phase II clinical study of the combination of avelumab plus cetuximab in the second line treatment of metastatic non small cell lung cancer (NSCLC) patients. - CAVE lung
A.O.U. Università degli Studi della Campania Luigi Vanvitelli0 个研究点目标入组 90 人开始时间: 2021年6月1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
- 90
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
- •Subjects with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression.
- •Subjects must have progressed after an acceptable therapy defined as follows:
- •a. Subjects must have progressed during or after a minimum of 2 cycles of 1 course of a platinum-based combination therapy or immunotherapy or a combination of both administered for the treatment of metastatic disease. A history of continuation (use of a non-platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination.
- •b. Subjects must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease.
- •Subjects with non-squamous cell NSCLC of unknown EGFR mutational status or ALK rearrangement will require testing (local laboratory). Subjects with a tumor that harbors an activating EGFR mutation or ALK rearrangement will not be eligible.
- •ECOG PS of 0 to 1 at trial entry.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Systemic anticancer therapy administered after disease progression during or following a platinum-based combination.
- •Subjects with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Subjects of unknown ALK and/or EGFR mutation status will require testing at screening.
- •Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.
- •All subjects with brain metastases, except those meeting the following criteria:
- •a. Brain metastases have been treated locally, and
- •b. No ongoing neurological symptoms that are related to the brain localization of the disease.
- •Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
研究者
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