EUCTR2018-002382-19-DE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: 2020年5月26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, non-smallcell lung cancer (NSCLC). The stage of the disease is evaluated according
- •to the classification of the American Joint Committee on Cancer, 8th edition.
- •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 treated,
- •Subjects with symptomatic CNS metastases must be either off corticosteroids, or on a stable or decreasing dose of =10mg daily prednisone (or equivalent) during at least 2 weeks before baseline.
- •7.For female patients without child-bearing potential: a documentation of tubal ligation or hysterectomy, ovariectomy or a post-menopausal
- •status is available.
- •For female patients of child-bearing potential: a negative serum pregnancy test at screening is required. The patient agrees to use a highly effective contraception method from signing informed consent form (screening), throughout the study treatment period with PDC*lung01 and for at least 28 days after the last administration of PDC*lung01.
- •For female patients receiving Pemetrexed in cohorts
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 required).
- •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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