NL-OMON49358已完成2 期
Combining SBRT and pembrolizumab in early stage non-small cell lungcancer patients planned for surgery: exploring safety and immunological proof of principle. - Combining radiotherapy and immunotherapy in early stage NSCLC patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
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 64（—）
入选标准
- •Histologically or cytologically confirmed diagnosis of early stage (T1cN0,
- •T2aN0 and T2bN0 ) peripherally located NSCLC, eligible for surgical resection.
- •Highly suspected NSCLC is defined as an a priori change of >85% that the
- •lesion is malignant, according to the publication of Herder et al. (59)
- •Be willing and able to provide written informed consent/assent for the trial.
- •Be 18 years of age or older on day of signing imformed consent.
- •Have measurable disease based on RECIST 1.1.
- •Must provide tissue from a core or excisional biopsy of the primary tumor
- •Have a performance status of 0-1 on the ECOG Performance Scale.
- •Demonstrate adequate organ function as defined in Table 1, all screening labs
- •should be performed within 10 days of treatment initiation.
- •Female subject of childbearing potential should have a negative urine or serum
- •pregnancy within 72 hours prior to receiving the first dose of study
- •medication. If the urine test is positive or cannot be confirmed as negative, a
- •serum pregnancy test will be required.
- •Female subjects of childbearing potential should be willing to use two methods
- •of birth control or be surgically sterile, or abstain from heterosexual
- •activity for the course of the study through 120 days after the last dose of
- •study medication. Subjects of childbearing potential are those who have not
- •been surgically sterilized or have not ben free form menses for >1 year.
- •Male subjects should agree to use an adequate method of contraception starting
- •with the first dose of study therapy through 120 days after the last dose of
- •study therapy.
排除标准
- •Is currently participating in or has participated in a study of an
- •investigational agent or using investigational device within 4 weeks of the
- •first dose of treatment.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or
- •any other form of immunosuppressive therapy within 7 days proor to the first
- •dose of trial treatment.
- •Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who
- •has not recovered (i.e. grade 1 or lower, or at baseling) from adverse events
- •due to agents administered more than 4 weeks earlier.
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation
- •therapy within 2 weeks prior to study day 1 or who has not recovered (i.e.
- •grade 1 or lower at baseline) from adverse events due to a previously
- •administered agent.
- •Has a known additional malignancy that is progressing or requires active
- •treatment. Exceptions include basal cell carcinoma of the skin, squamous cel
- •carcinoma of the skin, or in situ cervical cancer that has undergone
- •potentially curative therapy.
- •Has an active autoimmune disease requiring systemic treatment within the past 3
- •months or a documented histroy of clinically severe autoimmune disease, or a
- •syndrome that requires systemic steroids or immunosuppressive agents. Subjects
- •with vitiligo or resolved childhood asthma/atopy would be an exception to this
- •rule. Subjects that require intermittent use of bronchodilators or local
- •steroid injections would not be excluded from the study. Subjects with
- •hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be
- •excluded from the study.
- •Has a history of (non-infectious) pneumonitis that required steroids, evidence
- •of interstitial lung disease or active, non-infectious pneumonitis.
- •Has an active infection requiring systemic therapy.
- •Has a histroy or current evidence of any condition ,therapy or laboratory
- •abnormality that might confound the results of the trial, interfere with the
- •subject's participation for the full duration of the trial, or is not in the
- •bst interest of the subject to participate, in the opinion of the treating
- •investigator.
- •Has known psychiatric or substance abude disorders that would interfere with
- •cooperation with the requirements of the trial.
- •Is pregnant or breastfeedig, or expecting to conceive or father children within
- •the projected duration of the trial, starting with the pre-screening or
- •screening visit through 120 days after the last dose of trial treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2,
- •anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)
- •antibody (including ipilimumab or any other antibody or drug specifically
- •targeting T-cell co-stimulation or checkpoint pathways).
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA
- •[qualitative] is detected).
- •Has received a live vaccine within 30 days prior to the first dose of trial
研究者
相似试验
进行中（未招募）
1 期
Combining radiotherapy and immunotherapy in early stage non-small-cell lung cancer patients: exploring safety and immunological proof of principle.Early stage (T1N0 and T2N0) non-small cell lung cancerEUCTR2016-003819-36-NLVU Medical Centre30
Unknown
2 期
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid TumorsNon Small Cell Lung CancerSolid TumorNCT04571632Universitair Ziekenhuis Brussel36
已完成
1 期
Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by SurgeryNCT03021460Mayo Clinic20
进行中（未招募）
1 期
Pembrolizumab and trastuzumab in combination with chemotherapy before and after surgery for patients with HER2-positive gastric cancer - PHERFLOT –HER2 positive, localized esophagogastric adenocarcinomaMedDRA version: 20.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: PTClassification code 10066896Term: HER2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-006512-87-DEFrankfurter Institut für Klinische Krebsforschung IKF GmbH30
进行中（未招募）
1 期
Phase II trial of Pembrolizumab in combination with Doxorubicin in Advanced, Recurrent or Metastatic Endometrial Cancer (TOPIC)Advanced, Recurrent or Metastatic Endometrial CancerMedDRA version: 12.0 Level: HLGT Classification code 10007129 Term: Cancer-related morbidities System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-002824-26-ESVall d' Hebron Institute of Oncology (VHIO)51