NL-OMON56303尚未招募2 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) - Safety, immunogenicity & clinical activity study of PDC*lung01 in NSCLC
PDC*line Pharma SAS0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 11
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 99（—）
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.. Screening: 1.Patients with
- •histologically proven, or cytologically proven, non-small-cell 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, (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, B2 and C1): -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 provided. The patient agrees to use a highly effective
- •contraception method from signing informed consent form (screening
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 is receiving systemic corticosteroids at a
- •dose level exceeding 10 mg/day (prednisone or equivalent) during the screening
- •period (administration by nasal spray, topical solution or oral inhaler is
- •non-systemic and is therefore allowed). 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.
研究者
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