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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

September 10, 2019

Primary Completion Date

July 18, 2024

Study Completion Date

December 31, 2025

Conditions
Non Small Cell Lung Cancer
Interventions
BIOLOGICAL

PDC*lung01

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.

DRUG

Keytruda Injectable Product

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.

DRUG

Alimta 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.

Trial Locations (16)

3000

University Hospitals KU Leuven, Leuven

3500

Jessa Ziekenhuis, Hasselt

4000

CHU Liège- Sart Tilman, Liège

6000

Grand Hôpital de Charleroi, Charleroi

8500

AZ Groeninge, Kortrijk

8800

AZ Delta vzw, Roeselare

9100

AZ Sint-Nikolaas, Sint-Niklaas

38043

CHU Grenoble, Grenoble

44093

CHU Nantes, Nantes

51067

Kliniken der Stadt Köln GmbH, Cologne

60385

Universitätsklinikum Franlkfurt, Frankfurt am Main

69373

Centre Léon Bérard, Centre de lutte contre le cancer, Lyon

5223 GZ

Jeroen Bosch Ziekenhuis - 's hertogenbosch, 's-Hertogenbosch

1066 CX

Antoni Van Leeuwenhoek (Nederlands Kanker Instituut), Amsterdam

2333 ZA

Leiden University Medical Center (LUMC), Leiden

80-214

University Clinical Centre, Gdansk

Sponsors
All Listed Sponsors
lead

PDC*line Pharma SAS

INDUSTRY