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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*lung, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer (NSCLC).

The therapeutic cancer vaccine PDC*lung 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*lung will be administered to approximatively 64 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 Standard of Care (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*lung treatment visits with low dose/high dose administered successively by subcutaneous and then by intravenous route. In cohort B1 and B2, the first PDC*lung injection will start within 48 hours after the first infusion of anti-PD-1. The fourth PDC*lung 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*lung(visits V1 to V6), a post-treatment immuno-monitoring visit (V7, 1 week after the last injection) and an end-of-treatment (or early-termination) visit (V8, 4 weeks after the last injection); and a follow-up period starting after the end-of-treatment visit V8 (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, France, Netherlands, Germany and in Poland.

Overall Lead Investigator Belgium: Prof Johan Vansteenkiste (University Hospitals KU Leuven).

Lead Investigator France: Dr Maurice Pérol (Centre Léon Bérard, Centre de lutte contre le cancer).

Lead Investigator Germany: Dr Jessica Jürgens (Pneumologischen Klinik Lungenkrebszentrum Köln- Merheim).

Lead Investigator The Netherlands: Dr Willemijn Theelen (Nederlands Kankerinstituut [NKI] Antoni Van Leeuwenhoek).

Lead Investigator Poland: Dr Marcin Skrzypski (Department of Oncology and Radiotherapy Medical University of Gdańsk).
Study timelines

Start: June 2019.

Primary study completion (active period): September 2024.

Study completion: January 2026.
Study status 

Belgium: Approved by the Authorities, recruitment completed.

France: Approved by the Authorities, recruitment completed.

Germany: Approved by the Authorities, recruitment completed.

Netherland: Approved by the Authorities, recruitment completed.

Poland: Approved by the Authorities, recruitment completed.