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

Phase 1

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Biological: PDC*lung01; Drug: Keytruda Injectable Product; Drug: Alimta Injectable Product

• Registration Number: NCT03970746
• Lead Sponsor: PDC*line Pharma SAS

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Study Start: 2019-09-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort B2	Keytruda Injectable Product	PDC\*lung01 High Dose added to SoC, i.e., anti-PD-1 treatment
Cohort A1	Alimta Injectable Product	PDC\*lung01 Low Dose
Cohort A2	PDC*lung01	PDC\*lung01 High Dose
Cohort B1	PDC*lung01	PDC\*lung01 Low Dose added to SoC, i.e., anti-PD-1 treatment
Cohort B1	Keytruda Injectable Product	PDC\*lung01 Low Dose added to SoC, i.e., anti-PD-1 treatment
Cohort A1	PDC*lung01	PDC\*lung01 Low Dose
Cohort A2	Alimta Injectable Product	PDC\*lung01 High Dose
Cohort B2	PDC*lung01	PDC\*lung01 High Dose added to SoC, i.e., anti-PD-1 treatment

Primary Outcome Measures

Name	Time	Method
Occurrence of dose-limiting toxicities (DLT) related to the administration of PDC*lung01	Up to one week after the last injection (Day 42)

Secondary Outcome Measures

Name	Time	Method
Occurrence of serious adverse events (SAEs) and adverse events (AEs)	Up to Day 63
Occurrence of serious adverse events (SAEs) and adverse events (AEs), deemed as related to the association of PDC*lung01 and the anti-PD-1 therapy	Up to Day 63
Detection of anti-HLA class I and II antibodies in the serum	Screening, Day 35 and Day 63
Ex vivo detection and characterization of CD8+ T cells against tumor antigens borne by PDC*lung01, using flow cytometry	Screening, Day 35 and Day 63
Objective Response Rate (according to RECIST version 1.1 for cohorts A1/A2 and iRECIST for cohorts B1/B2)	Day 63
Progression-Free Survival	9 months from the first day of platinum-based or anti-PD-1 antibody administration

Trial Locations

Locations (16)

CHU Nantes; 🇫🇷 Nantes, France

Kliniken der Stadt Köln GmbH; 🇩🇪 Köln, Germany

CHU Grenoble; 🇫🇷 Grenoble, France

Universitätsklinikum Franlkfurt; 🇩🇪 Frankfurt am main, Germany

CHU Liège- Sart Tilman; 🇧🇪 Liège, Belgium

AZ Delta vzw; 🇧🇪 Roeselare, Belgium

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Belgium

University Hospitals KU Leuven; 🇧🇪 Leuven, Belgium

AZ Sint-Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Antoni Van Leeuwenhoek (Nederlands Kanker Instituut); 🇳🇱 Amsterdam, Netherlands

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

University Clinical Centre; 🇵🇱 Gdańsk, Poland

Jeroen Bosch Ziekenhuis - 's hertogenbosch; 🇳🇱 's Hertogenbosch, Netherlands

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Netherlands

Centre Léon Bérard, Centre de lutte contre le cancer; 🇫🇷 Lyon, France