2024-516195-15-00招募中3 期
Dose tapering and Early Discontinuation to InCreAse cosT-effictIveness Of immunotherapy for Non-small cell lung carcinoma trial number 1 (NVALT-30 - Dedication-1)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 31
- 主要终点
- The primary study parameter is the overall survival rate at one year.
研究概览
简要总结
To investigate the non-inferiority of reduced dose versus standard of care dose of pembrolizumab for treatment of advanced stage NSCLC in terms of overall survival.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.
- •Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- •Subjects with cytologically or histologically confirmed advanced stage or recurrent NSCLC (per the 8th International Association for the Study of Lung Cancer classification), eligible for treatment with pembrolizumab in line with ESMO guidelines.
- •Known PD-L1 status (performed on cytology or histology).
- •Subjects are aged ≥ 18 years.
- •Women must not be breastfeeding.
- •Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of 5 months (30 days of ovulatory cycle plus the time required for the investigational drug to undergo five half-lives) after end of pembrolizumab treatment.
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of 7 months (90 days plus the time required for pembrolizumab to undergo five half-lives) after the last dose of investigational drug. In addition, male participants must be willing to refrain from sperm donation during this time.
排除标准
- •Subjects with symptomatic untreated CNS metastases are excluded. i) Subjects are eligible if CNS metastases are asymptomatic or adequately treated and neurological symptoms have returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrolment. ii) In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment assignment.
- •Total body weight <40 or >140 kg.
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrolment. Inhaled or topical steroids, and steroids for adrenal replacement therapy are permitted.
- •A known CD4+ T-cell count of less than 100 cells/μL (CD4+ T cell count measurement is not required for patients without a history of low CD4+ T cell counts or HIV).
- •Prior treatment 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 checkpoint pathways.
- •Treatment with adjuvant or neoadjuvant chemotherapy 3 months prior to enrolment.
- •Non-palliative treatment with chemoradiation for locally advanced disease 3 months prior to enrolment. Palliative radiotherapy is allowed any time.
- •Women of childbearing potential (WOCBP) with a known pregnancy or a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) prior to the start of study treatment.
- •History of allergy or hypersensitivity to study drug components.
- •Subjects may not have previously received a solid organ transplantation.
结局指标
主要结局
The primary study parameter is the overall survival rate at one year.
The primary study parameter is the overall survival rate at one year.
次要结局
未报告次要终点
研究者
Demi Peeters
Scientific
Stichting Radboud universitair medisch centrum
研究点 (31)
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