NCT04497584进行中（未招募）2 期
An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Progression-free survival of combined afatinib and prednisone in previously treated NSCLC
研究概览
简要总结
To determine the efficacy of combined afatinib and prednisone in previously treated advanced squamous NSCLC
详细描述
This two-stage phase 2 study will determine the safety, tolerability, recommended phase 2 dose/maximum tolerated dose, preliminary efficacy and predictive/pharmacodynamic biomarkers of combined EGFR inhibition (afatinib) and TNF inhibition (prednisone) in previously treated NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
- •Previously treated (up to three prior lines of therapy), histologically proven advanced squamous NSCLC.
- •No prior treatment with EGFR inhibitors, IMIDs (eg, thalidomide, lenalidomide), or anti-TNF antibodies.
- •No treatment with systemic glucocorticoids within 3 weeks of initiation of study therapy (topical and inhaled glucocorticoids are permitted).
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ and marrow function as defined below:
- •absolute neutrophil count ≥ 1,000/μL
- •platelets ≥ 50,000/μl
- •total bilirubin within normal institutional limits
- •AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
- •CrCl ≥ 45 ml/min
- •For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
- •Adequate archival tissue (5-10 slides) for correlative studies.
- •Subject must have measurable disease per RECIST 1.1
排除标准
- •Chemotherapy, radiotherapy, or other cancer therapy within two weeks prior to starting study treatment. Subjects must have recovered from prior treatment-related to toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
- •Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
- •Symptomatic brain metastases or brain metastases requiring escalating doses of corticosteroids
- •History of hypersensitivity or allergic reactions attributed to afatinib or prednisone.
- •Uncontrolled intercurrent illness including but not limited to poorly controlled diabetes (which may worsen in setting of chronic prednisone therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- •Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
研究组 & 干预措施
Afatinib + Prednisone
Experimental
Afatinib 40 mg PO daily
Prednisone 40 mg PO daily starting 7 days after Afatinib
干预措施: Afatinib + Prednisone (Drug)
结局指标
主要结局
Progression-free survival of combined afatinib and prednisone in previously treated NSCLC
时间窗: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Measure progression-free survival rate.
次要结局
- Overall survival of combined afatinib and prednisone in previously treated NSCLC(From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months)
- Safety of combined afatinib and prednisone in previously treated NSCLC(From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months)
- Response rate of combined afatinib and prednisone in previously treated NSCLC(From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months)
研究者
Sheena Bhalla
Assistant Professor of Medicine
University of Texas Southwestern Medical Center
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Study of Afatinib in Advanced Cutaneous Squamous Cell CarcinomaSquamous Cell CarcinomaNCT05070403H. Lee Moffitt Cancer Center and Research Institute35
Unknown
2 期
Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)Esophageal Squamous Cell CarcinomaNCT03940976Peking University40
已完成
2 期
Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain MetastasesBreast NeoplasmsNeoplasm MetastasisNCT01441596Boehringer Ingelheim121
Unknown
2 期
Afatinib Plus Toripalimab in Previously Treated ESCC With EGFR Overexpression or EGFR AmplificationEsophageal Squamous Cell CarcinomaNCT04880811Peking University43
Unknown
2 期
Adjuvant Therapy With Apatinib for HCC Patients With PVTT Who Underwent Radical ResectionCarcinoma, HepatocellularNCT03261791Shanghai Zhongshan Hospital30