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

NCT03970746 | Active Not Recruiting Phase 1

• 2 other identifiers: PDC-LUNG-1012018-002382-19
• Study Type: interventional
• Target: 73
• Locations: 5 countries
• Sites: 16

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Anti-PD-1

Outcome Measures

Primary Outcomes (1)

• Occurrence of dose-limiting toxicities (DLT) related to the administration of PDC*lung01

  Up to one week after the last injection (Day 42)

Secondary Outcomes (6)

• 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

• Occurrence of serious adverse events (SAEs) and adverse events (AEs)

  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

Study Arms (4)

Cohort A1

EXPERIMENTAL

PDC\*lung01 Low Dose

Biological: PDC*lung01; Drug: Alimta Injectable Product

Cohort A2

EXPERIMENTAL

PDC\*lung01 High Dose

Biological: PDC*lung01; Drug: Alimta Injectable Product

Cohort B1

EXPERIMENTAL

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

Biological: PDC*lung01; Drug: Keytruda Injectable Product

Cohort B2

EXPERIMENTAL

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

Biological: PDC*lung01; Drug: Keytruda Injectable Product

Interventions

PDC*lung01 BIOLOGICAL

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.

Cohort A1; Cohort A2; Cohort B1; Cohort B2

Keytruda Injectable Product DRUG

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.

Also known as: Pembrolizumab

Cohort B1; Cohort B2

Alimta Injectable Product DRUG

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.

Also known as: Pemetrexed

Cohort A1; Cohort A2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-screening:
• Documented HLA-A\*02:01 positivity after the patient has provided written informed consent.
• Only patients showing a documented positive result in pre-screening will be allowed to enter the screening period.
• Screening:
• Patients with histologically proven, or cytologically proven (allowed only for patients recruited in cohorts A1/A2), non-small-cell lung cancer (NSCLC). The stage of the disease is evaluated according to the classification of the American Joint Committee on Cancer, 8th edition (see Section 25.1)
• (i) Stage IIa/IIb/IIIa NSCLC following radical surgery (R0 resection) and, if applicable, following adjuvant platinum-based chemotherapy (Figure 2) -, or (ii) Stage IV histologically or cytologically confirmed case of epidermoid (squamous) lung cancer following 4 cycles of platinum-based therapy (Figure 3), if targeted treatment options were not indicated or (iii) Stage IV histologically or cytologically confirmed case of adenocarcinoma (non-squamous) lung cancer following 4 to 6 cycles of pemetrexed and platinum combination (Figure 3), if targeted treatment options were not indicated.
• (iv) Populations (ii) and (iii) who have stopped prematurely chemotherapy, after at least 2 cycles of platinum-based therapy, for any reason, AND do present with a documented stable disease or partial / complete response.
• For the anti-PD-1 immunotherapy (Cohorts B1 and B2):
• The patient has first-line metastatic stage IV NSCLC measurable disease and is starting anti-PD-1. The intention and decision to prescribe the anti-PD-1 monotherapy as SoC (TPS≥50%), assuming no targeted mutation detected, following standard NGS testing, if applicable, and thus no targeted treatment option is indicated, must have been made by the investigator before and regardless of the patient's participation in the study. Radiotherapy/chemoradiotherapy for prior stage III NSCLC is allowed if the treatment-free interval is \>1 year.
• ECOG performance status 0 or 1.
• Adequate renal and hepatic function as defined below:
• Serum creatinine clearance \> 50 mL/min (Cockcroft-Gault formula)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN (up to 5 times ULN are allowed in case of presence of liver metastases).
• Adequate haematological function as defined below:

You may not qualify if:

• Mixed small-cell and non-small-cell histological features.
• Patient has documented evidence of EGFR mutation, ALK fusion or ROS1 fusion (according to current ESMO clinical practice guidelines) or any mutation for which targeted treatment options would be indicated, as per SoC.
• Patient has received immunotherapy or any investigational drugs within 4 weeks before the first PDC\*lung01 dose. Chemoradiotherapy with consolidation durvalumab for prior stage III disease.
• Patient with Stage IV disease that received prior radiotherapy (except palliative radiotherapy e.g. brain irradiation). Palliative radiotherapy for stage IV disease should be completed one week prior to baseline visit and for brain irradiation a 2-week window is required.
• Patient without brain metastasis is receiving systemic corticosteroids at a dose level exceeding 10 mg/day (prednisone or equivalent) during the screening period (administration by nasal spray, topical solution or oral inhaler is non-systemic and is therefore allowed).
• Patient has a medical history of cancer other than NSCLC, except the following: (i) non-melanoma skin cancer with complete resection, (ii) in situ carcinoma of the cervix, (iii) other cancer treated with no evidence of disease for at least five years.
• Known hepatitis B and/or C infection (testing not required).
• Known positive for human immunodeficiency virus (HIV; testing not required).
• Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months of baseline) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable).
• Any history of splenectomy or splenic irradiation.
• For female patients: pregnancy or lactation.
• Any condition, including autoimmune or immunodeficiency active disease that, in the opinion of the Investigator, would jeopardise patient's safety, or might compromise the effect of the study drug or the assessment of the study result. Patients with vitiligo, diabetes Type I, psoriasis (not requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, or oral corticosteroids within the previous 12 months) or a history of autoimmune thyroiditis are not excluded.
• Specific for patients enrolled in France: Patient is under legal protection.

Sponsors & Collaborators

• PDC*line Pharma SAS: lead

Study Sites (16)

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

University Hospitals KU Leuven

Leuven, 3000, Belgium

Location

CHU Liège- Sart Tilman

Liège, 4000, Belgium

Location

AZ Delta vzw

Roeselare, 8800, Belgium

Location

AZ Sint-Nikolaas

Sint-Niklaas, 9100, Belgium

Location

CHU Grenoble

Grenoble, 38043, France

Location

Centre Léon Bérard, Centre de lutte contre le cancer

Lyon, 69373, France

Location

CHU Nantes

Nantes, 44093, France

Location

Kliniken der Stadt Köln GmbH

Cologne, 51067, Germany

Location

Universitätsklinikum Franlkfurt

Frankfurt am Main, 60385, Germany

Location

Jeroen Bosch Ziekenhuis - 's hertogenbosch

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Antoni Van Leeuwenhoek (Nederlands Kanker Instituut)

Amsterdam, 1066 CX, Netherlands

Location

Leiden University Medical Center (LUMC)

Leiden, 2333 ZA, Netherlands

Location

University Clinical Centre

Gdansk, 80-214, Poland

Location

Related Links

• PDC\*line Pharma website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Johan Vansteenkiste, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 31, 2019
• Study Start: September 10, 2019
• Primary Completion: July 18, 2024
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); DE (2); BE (7); FR (3); NL (3)