Safety, immunogenicity and preliminary clinical activity study of PDC*lung01 cancer vaccine in NSCLC

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 66

Inclusion Criteria

Pre-screening:
Documented HLA-A*02:01 positivity after the patient has provided written informed consent to participate in the study.

Screening:
1.Patients with histologically proven, or cytologically proven (allowed only for patients recruited in cohorts A1/A2), 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 (see Section 25.1)
a.For the dose-escalation phase (Cohorts A1 and A2): a wash-out period of at least 4 weeks after administration of the last cycle of platinum-based chemotherapy is required.
(i)Stage IIa/IIb/IIIa NSCLC following surgery and, if applicable, adjuvant platinum-based chemotherapy, or
(ii)Stage IV histologically or cytologically confirmed case of epidermoid (squamous) NSCLC following 4 courses of platinum-based therapy, or
(iii)Stage IV histologically or cytologically confirmed case of adenocarcinoma (non-squamous) lung cancer NSCLC following 4 to 6 courses cycles of pemetrexed and platinum combination,
(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 control disease.
b.For the anti-PD-1 immunotherapy (Cohorts B1 and B2):
-The patient has first-line metastatic stage IV NSCLC disease and is starting anti-PD-1. The intention and decision to prescribe the anti-PD-1 monotherapy as SoC (TPS=50%) must have been made by the investigator before and regardless of the patient’s participation in the study.
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, among which = 10 % of CD8+ T cells and
•absolute neutrophil count: >1.5x10^9/L,
•Haemoglobin = 90 g/L
5.Patient willing and able 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 and have been treated,
•In addition, subjects 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 practice a double barrier” contraception for at least 30 days before the first of administration of PDC*lung01, throughout the study treatment period and for at least 28 days after the last administration of PDC*lung01.
8. Males with reproductive potential should use barrier method of contraception (condom) from screening up to at least 28 days after the last dose of PDC*lung01
9. In the Investigator’s opinion, the patient is able and willing to comply with the requirements of the study.
10. Patient willing and able to sign the stud

Exclusion Criteria

1.Mixed small-cell and non-small-cell histological features.
2.Patient has received immunotherapy or any investigational drugs within 4 weeks before the first PDC*lung01 dose.
3.Patient is receiving systemic corticosteroids at a dose level exceeding 10 mg/day (prednisone or equivalent) OR he/she has been receiving systemic corticosteroids for a period longer than 10 days before baseline (administration by nasal spray, topical solution or oral inhaler is non-systemic and is therefore allowed).
4.Patient has a medical history of cancer other than NSCLC, except the following: (i) non-melanoma skin cancer with complete resection, (ii) in situ carcinoma of the cervix, (iii) other cancer treated with no evidence of disease for at least five years.
5.Patient presents at screening anti-HLA antibodies against HLA molecules expressed by the PDC*line.
6.Known hepatitis B and/or C infection (testing not required).
7.Known positive for human immunodeficiency virus (HIV; testing not required).
8.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).
9.Any history of splenectomy or splenic irradiation.
10.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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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