PHASE 1 / 2

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 (NSCLC).

The therapeutic cancer vaccine PDC*lung01 includes, in similar proportion, seven active agents, made of irradiated human plasmacytoid dendritic cells (PDC) loaded separately with a distinct synthetic peptide encoded by a lung tumor antigen, namely NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE (an epitope common to several MAGE-A antigens), SURVIVN, MUC1 or a peptide derived from the Melan-A antigen.

PDC*lung01 will be administered to approximatively 66 evaluable NSCLC patients 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 PDC*lung01 injection will start within 48 hours after the first infusion of anti-PD-1. The fourth PDC*lung01 injection will occur at the same time as the second cycle of anti-PD-1.

The study will be divided in two parts: one active period comprising screening, treatment with PDC*lung01(visits V1 to V6) and an end-of-treatment (or early-termination) visit (V7, 4 weeks after the last injection); and a follow-up period starting after the end-of-treatment visit V7 (or early-termination visit) up to 2 years.

Study Number

EudraCT number: 2018-002382-19
Title

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)

Population 

HLA-A*02:01 positive patients with non-small-cell lung cancer (NSCLC).

In cohorts A1/A2: PDC*lung01 will be administered to patients in adjuvant or first line stage IV NSCLC in maintenance setting.

In cohorts B1/B2: PDC*lung01 will be administered to patients with first-line metastatic stage IV NSCLC disease 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.    

Country lead Principal Investigators 

Clinical sites in Belgium and in France

Coordinating Investigator Belgium and Overall Study: Prof. Johan Vansteenkiste

Coordinating Investigator France: Prof. Fabrice Barlesi

Study timelines

Start: June 2019

Primary study completion (active period): November 2020

Study completion: August 2022

Study status 

Belgium: Approved by the Authorities, not recruiting yet.

France: Clinical Trial Application under review by the Authorities.