EUCTR2018-002382-19-PL进行中（未招募）1 期
An open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer (NSCLC)
PDC*line Pharma SAS0 个研究点目标入组 64 人开始时间: 2021年6月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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
- •Pre-screening:
- •Documented HLA-A*02:01 positivity and absence of anti-HLA antibodies
- •against HLA molecules expressed by the PDC*line, after the patient has
- •provided written informed consent.
- •1.Patients with histologically proven, or cytologically proven, nonsmallcell
- •lung cancer (NSCLC). The stage of the disease is evaluated
- •to the classification of the American Joint Committee on Cancer, 8th
- •a.For the dose-escalation phase (Cohorts A1 and A2):
- •(i)Stage IIa/IIb/IIIa NSCLC following radical surgery (R0 resection)
- •and, if applicable, adjuvant platinum-based chemotherapy, or
- •(ii)Stage IV histologically or cytologically confirmed case of epidermoid
- •(squamous) lung cancer following 4 cycles of platinum-based therapy, if
- •targeted treatment options were not indicated, or
- •(iii)Stage IV histologically or cytologically confirmed case of
- •adenocarcinoma (non-squamous) lung cancer following 4 to 6 cycles of
- •pemetrexed and platinum combination, if targeted treatment options
- •were not indicated, or
- •(iv)Populations (ii) and (iii) who have stopped prematurely
- •chemotherapy, after at least 2 cycles of platinum-based therapy, for any
- •reason, AND do present with a documented stable disease or partial /
- •complete response.
- •b.For the anti-PD-1 immunotherapy (Cohorts B1 and B2):
- •-The patient has first-line metastatic stage IV NSCLC measurable disease
- •and is starting anti-PD-1. The intention and decision to prescribe the
- •anti-PD-1 monotherapy as SoC (TPS=50%), assuming no targeted
- •mutation detected, following standard NGS testing, if applicable, and
- •thus no targeted treatment option is indicated, must have been made by
- •the investigator before and regardless of the patient's participation in
- •the study. Radiotherapy/chemoradiotherapy for prior stage III NSCLC is
- •allowed if the treatment-free interval is >1 year.
- •2.ECOG performance status 0 or 1.
- •3.Adequate renal and hepatic function as defined below:
- •Serum creatinine clearance > 50 mL/min (Cockcroft–Gault formula)
- •Bilirubin = 1.5 times upper limit of normal (ULN)
- •Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5
- •times ULN (up to 5 times ULN are allowed in case of presence of liver
- •metastases).
- •4.Adequate haematological function as defined below:
- •Platelet count = 70x10^9 /L;
- •White blood cell count = 2.5 x 10^9 /L with
- •lymphocytes >1x10^9 /L, at screening or at baseline and
- •absolute neutrophil count: >1.5x10^9/L,
- •Haemoglobin = 90 g/L
- •5.Patient willing to provide a baseline blood sample for leucocyte
- •enumeration, cellular allogeneic response and immune-monitoring of
- •100 ml in total (in one or two samplings).
- •6.For patients with brain metastases:
- •Central nervous system metastases are not symptomatic or have been
- •Subjects with symptomatic CNS metastases must be either off
- •corticosteroids, or on a stable or decreasing dose of =10mg daily
- 另有 11 项未显示
排除标准
- •1.Mixed small-cell and non-small-cell histological features.
- •2.Patient has previously documented evidence of EGFR mutation, ALK
- •fusion or ROS1 fusion (according to current ESMO clinical practice
- •guidelines) or any mutation for which targeted treatment options would
- •be indicated, as per SoC.
- •3.Patient has received immunotherapy or any investigational drugs
- •within 4 weeks before the first PDC*lung01 dose. Chemoradiotherapy
- •with consolidation durvalumab for prior stage III disease.
- •4. Patient with Stage IV disease that received prior radiotherapy (except
- •palliative radiotherapy e.g. brain irradiation). Palliative radiotherapy for
- •stage IV disease should be completed one week prior to baseline visit
- •and for brain irradiation a 2-week window is required.
- •5.Patient without brain metastasis has been receiving a dose of systemic
- •corticosteroid exceeding 10mg during the screening period.
- •6.Patient has a medical history of cancer other than NSCLC, except the
- •following: (i) non-melanoma skin cancer with complete resection, (ii)
- •adequately treated carcinoma in situ, (iii) other cancer treated with no
- •evidence of disease for at least five years with the exception of pT1-2
- •prostatic cancer Gleason score < 6 and superficial bladder cancer.
- •7.Known hepatitis B and/or C infection (testing not required).
- •8.Known positive for human immunodeficiency virus (HIV; testing not
- •9.Uncontrolled congestive heart failure or hypertension, unstable heart
- •disease (coronary artery disease with unstable angina or myocardial
- •infarction within 6 months of baseline) or uncontrolled ventricular
- •arrhythmias at the time of enrolment in the study (atrial fibrillation or
- •flutter is acceptable).
- •10.Any history of splenectomy or splenic irradiation.
- •11.For female patients: pregnancy or lactation.
- •12.Any condition, including autoimmune or immunodeficiency active
- •disease that, in the opinion of the Investigator, would jeopardise
- •patient's safety, or might compromise the effect of the study drug or the
- •assessment of the study result. Patients with vitiligo, diabetes Type I,
- •psoriasis (not requiring psoralen plus ultraviolet A radiation,
- •methotrexate, retinoids, or oral corticosteroids within the previous 12
- •months) or a history of autoimmune thyroiditis are not excluded.
- •13. Specific for patients enrolled in France: Patient is under legal
- •protection.
研究者
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