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PDC\*lung01 Low Dose added to SoC, i.e., anti-PD-1 treatment

PDC\*lung01 High Dose added to SoC, i.e., anti-PD-1 treatment

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, MAGEA4, Multi-MAGE (an epitope common to several MAGE-A antigens), SURVIVN, MUC1 or a peptide derived from the Melan-A antigen.

PDC*lung01

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.

Keytruda Injectable Product

For patients with non-squamous NSCLC included in Cohorts A1 and A2, maintenance by pemetrexed (IV every 3 weeks) can be administered according to SoC.

Alimta Injectable Product

Johan Vansteenkiste, Prof

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 PDC\*lung01 injection will start within 48 hours after the first infusion of anti-PD-1. The fourth PDC\*lung01 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-A\*02:01 positivity), only patients with positive HLA-A\*02:01 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), a V7 one week after the last injection and an end-of-treatment (EoT) visit (V8, 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.

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC

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)

PDC*line Pharma SAS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC	NCT03970746	Non Small Cell ...	PDC*lung01 Keytruda Inject... Alimta Injectab...	18 Years -	PDC*line Pharma SAS
Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC	NCT03970746	Non Small Cell ...	PDC*lung01 Keytruda Inject... Alimta Injectab...	18 Years -	PDC*line Pharma SAS
Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC	NCT03970746	Non Small Cell ...	PDC*lung01 Keytruda Inject... Alimta Injectab...	18 Years -	PDC*line Pharma SAS

**Spots Global Cancer Trial Database for pdc*lung01**

Every month we try and update this database with for pdc*lung01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pdc*lung01

Every month we try and update this database with for pdc*lung01 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

**Spots Global Cancer Trial Database for pdc*lung01**

Every month we try and update this database with for pdc*lung01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.