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Non Small Cell Lung CancerPhase 1/2NCT03970746

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

A Phase 1/2 study testing PDC*lung01, Keytruda Injectable Product and Alimta Injectable Product in people with Non Small Cell Lung Cancer, run by PDC*line Pharma SAS at 16 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
PDC*lung01, Keytruda Injectable Product and Alimta Injectable Product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
16 sitesin 5 countries
Study dates
10 Sep 2019to Dec 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-screening:
  • Documented HLA-A02:01 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.
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  • 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:
  • Platelet count ≥ 70 x 10⁹/L;
  • White blood cell count ≥ 2.5 x 10⁹/L with
  • lymphocytes ≥ 1 x 10⁹/L, among which ≥ 10 % of CD8+ T cells at screening or at baseline and
  • absolute neutrophil count ≥ 1.5 x 10⁹/L;
  • Haemoglobin ≥ 90 g/L
  • Patient willing and able to provide a baseline blood sample for leucocyte enumeration, cellular allogeneic response and immune-monitoring of 100 ml in total (in one or two samplings).
  • For patients with brain metastases:
  • Central nervous system metastases are not symptomatic and have been treated,
  • In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent) during at least 2 weeks before baseline.
  • For female patients without child-bearing potential: a documentation of tubal ligation or hysterectomy, ovariectomy or a post-menopausal status is available.
  • For female patients of child-bearing potential: a negative serum pregnancy test at screening is required. The patient agrees to use a highly effective contraception method from signing informed consent form (screening), throughout the study treatment period with PDClung01 and for at least 28 days after the last administration of PDClung01.
  • For female patients receiving Pemetrexed in cohorts A1/A2 concomitantly with PDClung01, according to corresponding SmPC, it is required to use effective contraception during treatment with pemetrexed.
  • For female patients receiving Pembrolizumab in cohorts B1/B2 concomitantly with PDClung01, according to corresponding SmPC, it is required to use an effective method of contraception up to 4 months thereafter.
  • A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
  • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • "Highly effective" contraceptive measures acceptable for the whole duration of the study have been defined based on the CTFGs recommendations on contraception and are the following:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Monogamous relationship with a vasectomized partner. Partner must have been vasectomized for at least 6 months before the participant entered into the study
  • Abstinence or absence of sexual relations with men.
  • Males with reproductive potential should use barrier method of contraception (condom) from signing informed consent form (screening) up to at least 28 days after the last dose of PDC*lung01.
  • For male patients receiving Pemetrexed in cohorts A1/A2 concomitantly with PDClung01, according to corresponding SmPC, it is required to use barrier method of contraception up to 6 months thereafter.
  • In the Investigator's opinion, the patient is able and willing to comply with the requirements of the study.
  • Patient willing and able to sign the study informed consent form before any study-specific procedures are conducted.
  • Patient (male or female) is aged 18 years or above.
  • Specific for patients enrolled in France: Patient is affiliated to a health insurance system.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

16 sites in 5 countries.

16 sites in 5 countries

Belgium7 sites

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • Jessa Ziekenhuis

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • University Hospitals KU Leuven

    Leuven, 3000

  • CHU Liège- Sart Tilman

    Liège, 4000

  • AZ Delta vzw

    Roeselare, 8800

  • AZ Sint-Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

France3 sites

  • CHU Grenoble

    Grenoble, 38043

  • Centre Léon Bérard, Centre de lutte contre le cancer

    Lyon, 69373

  • CHU Nantes

    Nantes, 44093

Other trials in France

Netherlands3 sites

  • Jeroen Bosch Ziekenhuis - 's hertogenbosch

    's-Hertogenbosch, 5223 GZ

  • Antoni Van Leeuwenhoek (Nederlands Kanker Instituut)

    Amsterdam, 1066 CX

  • Leiden University Medical Center (LUMC)

    Leiden, 2333 ZA

Other trials in Netherlands

Germany2 sites

  • Kliniken der Stadt Köln GmbH

    Cologne, 51067

  • Universitätsklinikum Franlkfurt

    Frankfurt am Main, 60385

Other trials in Germany

Poland1 site

  • University Clinical Centre

    Gdansk, 80-214

Other trials in Poland

About this study

Official 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)

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.

Read the 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.
Being tested
PDC*lung01, Keytruda Injectable Product, Alimta Injectable Product
Keywords
Anti-PD-1
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PDC*lung01Biological

    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.

  • Keytruda Injectable ProductDrug

    Also called Pembrolizumab

    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.

  • Alimta Injectable ProductDrug

    Also called Pemetrexed

    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.

Study groups in NCT03970746
Study groupRoleWhat they receive
Cohort A1ExperimentalPDC*lung01 Low Dose
Receives: Biological: PDC*lung01; Drug: Alimta Injectable Product
Cohort A2ExperimentalPDC*lung01 High Dose
Receives: Biological: PDC*lung01; Drug: Alimta Injectable Product
Cohort B1ExperimentalPDC*lung01 Low Dose added to SoC, i.e., anti-PD-1 treatment
Receives: Biological: PDC*lung01; Drug: Keytruda Injectable Product
Cohort B2ExperimentalPDC*lung01 High Dose added to SoC, i.e., anti-PD-1 treatment
Receives: Biological: PDC*lung01; Drug: Keytruda Injectable Product

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (6)

  1. 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

    Measured: Up to Day 63

  2. Occurrence of serious adverse events (SAEs) and adverse events (AEs)

    Measured: Up to Day 63

  3. Detection of anti-HLA class I and II antibodies in the serum

    Measured: Screening, Day 35 and Day 63

  4. Ex vivo detection and characterization of CD8+ T cells against tumor antigens borne by PDC*lung01, using flow cytometry

    Measured: Screening, Day 35 and Day 63

  5. Objective Response Rate (according to RECIST version 1.1 for cohorts A1/A2 and iRECIST for cohorts B1/B2)

    Measured: Day 63

  6. Progression-Free Survival

    Measured: 9 months from the first day of platinum-based or anti-PD-1 antibody administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start10 Sep 2019
  3. Primary completion18 Jul 2024
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03970746
Sponsor's protocol ID
PDC-LUNG-101
Other IDs
2018-002382-19, 2018
Status last verified
May 2025
First submitted
17 May 2019
Last updated
29 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PDC*lung01, Keytruda Injectable Product and Alimta Injectable Product in people with Non Small Cell Lung Cancer, run by PDC*line Pharma SAS at 16 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 43 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Belgium, France, Netherlands, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of dose-limiting toxicities (DLT) related to the administration of PDC*lung01 (time frame: Up to one week after the last injection (Day 42)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03970746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.

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