PDC-LUNG-101 trial is 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.
The therapeutic cancer vaccine, PDC*lung01 will be administered at two dose levels (low dose
(LD) and high dose (HD)), as single agent or during maintenance treatment by pemetrexed (for
adenocarcinomas in Cohorts A1 and A2) or added to the SoC (cohorts B1 and B2) i.e. anti-PD-1.
In cohorts A1 (low dose cohort) and A2 (high dose cohort), NSCLC patients will be treated at
each of the six PDC*lung01 treatment visits with low dose/high dose administered successively
by subcutaneous and then by intravenous route.
In cohort B1 and B2, the first PDClung01 injection will start within 48 hours after the
first infusion of anti-PD-1. The fourth PDClung01 injection will occur within 48 hours after
the infusion of the second cycle of anti-PD-1.
For each patient, the study will be divided into three consecutive parts:
Pre-screening (for HLA-A02:01 positivity), only patients with positive HLA-A02:01
status will be proposed to be screened.
Active period comprising a screening period, a treatment period (visits V1 to V6, during
which the patient receives PDC*lung01 vaccine, at each visit) and an end-of-treatment
(EoT) visit (V7, 4 weeks after the last injection),
Follow-up period which starts after the EoT visit and lasts up to two years after the
first IMP administration.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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