EUCTR2022-001284-27-AT进行中（未招募）1 期
H1-antihistaminE treatment in combiNation with immunotHerapy in pAtieNts with advanced non small cell lung canCEr: A single- center phase II trial - ENHANCE
Med. Univ. Wien, Klinik f. Innere Med I, Onkologie0 个研究点目标入组 9 人开始时间: 2022年7月14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
- 9
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
- •Capability of understanding the purpose of the study and have given written informed consent.
- •Histologically confirmed squamous or non-squamous NSCLC
- •Radiologically documented metastatic unresectable disease
- •Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
- •No previous systemic therapy for metastatic disease
- •Patients who are planned to receive pembrolizumab monotherapy in routine indication and according to the marketing authorisation
- •Patient with a history of adequately treated, asymptomatic CNS metastases are eligible, provided they meet all of the following criteria: Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord). No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed.
- •Age = 18 years
- •ECOG-PS 0-2, KPS >70%
- •Adequate bone-marrow, liver and kidney function – except of a tumor-associated dysfunction due to metastatic NSCLC disease
- •No previous systemic therapy for metastatic disease. Patients who received prior radio- and/or chemotherapy in neoadjuvant or adjuvant indications before study inclusion are allowed in consideration of an adequate washout period before the enrolment. Adequate treatment washout period before enrolment, defined as:
- •- Major Surgery: =4 weeks
- •- Radiation therapy: =4 weeks
- •- Chemotherapy: =2 weeks
- •- Systemic steroid-treatment: =2 weeks
- •Patient must be able to tolerate therapy
- •Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used in women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, from study start to the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Patients who received anti-CTLA4, or therapies targeting the PD-L1 and PD-1 pathway for early-stage NSCLC
- •A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •Patients requiring concomitant use of chronic systemic (IV or oral) corticosteroids higher than 10mg prednisolone per day or other immunosuppressive medications except for managing adverse events (inhaled steroids or intra articular steroid injections are permitted in this study)
- •Use of any investigational agent within 28 days prior to initiation of study treatment
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years
- •Presence of history of drug hypersensitivity of fexofenadine hydrochloride or other related products
- •Known autoimmune disease (with the exception of residual hypothyroidism on an autoimmune basis, diabetes mellitus type 1, psoriasis not requiring systemic treatment)
- •Hepatitis B or C infection
- •Pregnant or lactating women
- •Male subjects unable or unwilling to use adequate contraception methods
- •Patients with known substance abuse or any other medical conditions such as clinically significant neurological or psychological conditions, that may, in the opinion of the investigator, interfere with the subject’s participation in the clinical study or evaluation of the clinical study results
- •Patients who are unable to swallow
研究者
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