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Non-small Cell Lung CancerPhase 1NCT05195619

Personalized DC Vaccines in Non Small Cell Lung Cancer

A Phase 1 study testing Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine) and Low dose cyclophosphamide in people with Non-small Cell Lung Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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

Phase Ib clinical trial using autologous dendritric cell (DC) vaccine loaded with personalized peptides (PEP) given in combination with low-dose cyclophosphamide, as standard of care (SOC) therapy in patients with advanced or recurrent metastatic NSCLC. 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?
Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine) and Low dose cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSwitzerland
Study dates
22 Mar 2022to Jun 2027
Phase
Phase 1
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

  • Signed informed consent form
  • Histologically confirmed diagnosis of the NSCLC
  • Patients with metastatic, recurrent and/or unresectable NSCLC from stage IIIA (not amenable to radical treatment) to stage IVB provided they have not experienced disease progression on their current standard-of-care therapy at screening, as compared to the tumor assessment at the initiation of standard-of-care therapy as confirmed by Computed tomography/Magnetic Resonance Imaging (CT/MRI).
  • Patients may have received any number of prior treatments without restriction and any prior immunotherapy before enrollment to the study. However, only patients receiving the maintenance/continuation of standard of care (SOC) treatment options mentioned below are permitted to enter the study.
  • Patient may receive only the following maintenance/continuation of SOC therapy during study treatment, as indicated in each case.
  • Cohort 1: advanced or metastatic non-small cell lung cancer of any histology without any actionable oncogenic driver treated by SOC. Maintenance pemetrexed and/or maintenance pemetrexed + pembrolizumab, pembrolizumab alone, nivolumab, or atezolizumab is allowed.
Show all 25Show fewer
  • Cohort 2: advanced or metastatic NSCLC with actionable oncogenic driver such as Epidermal Growth Factor Receptor (EGFR) or anaplastic lymphoma kinase (ALK) or ROS-1-rearrangement, currently receiving osimertinib, alectinib, lorlatinib, brigatinib or crizotinib as per SOC in each disease entity
  • Top 10 personalized peptides (PEP) for the preparation of PEP-DC vaccine has been determined before screening.
  • Patients >18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 21 days prior registration:
  • Hemoglobin ≥ 90 g/L
  • Neutrophil count ≥ 1.0 G/L (independently of administration of growth factor within 4 weeks prior registration)
  • Platelet count ≥ 100 G/L
  • Serum creatinine ≤ 1.5x Institutional Upper Limit of Normal (ULN), or Creatinine clearance (CrCl) ≥ 40 mL/min (calculated using the Cockcroft-Gault formula.
  • Serum bilirubin ≤ 1.5 ULN (except subjects with Gilbert's syndrome who must have a total bilirubin level of <3.0 x ULN)
  • Aspartate Aminotransferase/Alanine Aminotransferase (AST/ALT) ≤ 3 x ULN
  • Alkaline phosphatase ≤ 1.5 x ULN
  • Coagulation (INR, PT, aPTT): International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Willing and able to comply with study procedures
  • For women of childbearing potential (WOCBP: sexually mature women who have not undergone a hysterectomy, have not been naturally post-menopausal for at least 12 consecutive months or have a serum follicle-stimulating hormone (FSH) < 40 mIU/ml):
  • Agreement to follow instructions for method(s) of contraception for the couple from screening until 6 months after last vaccine dose, or last cyclophosphamide
  • WOCBP must have a negative urine pregnancy test within 7 days, before registration. A positive urine test must be confirmed by a serum pregnancy test.
  • 13. For men and their female partners: agreement to follow instructions for method(s) of contraception for the couple from screening until 6 months after last vaccine dose, or last cyclophosphamide
  • 14. Patient is able to undergo leukapheresis

Who cannot join

  • Pregnant or breast-feeding women
  • Other malignancy within 2 years prior study enrollment, except for those treated with surgical intervention as curative intent in remission.
  • Current, recent (within 4 weeks prior registration), or planned participation in an experimental drug study
  • Patients who show signs of progression according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at screening
  • Planned SOC therapy other than the following:
  • Cohort 1: Maintenance pemetrexed and/or maintenance pemetrexed + pembrolizumab, pembrolizumab alone, nivolumab or atezolizumab is allowed.
Show all 43Show fewer
  • Cohort 2: osimertinib, alectinib, lorlatinib, brigatinib or crizotinib
  • Known hypersensitivity to any component of the study treatment
  • Any contraindication for using cyclophosphamide
  • Treatment with systemic immunosuppressive medications within 4 weeks prior vaccination (more than an equivalent of 10mg prednisone per day). Patient who has to receive steroid treatment as premedication before pemetrexed are eligible.
  • Administration of a live, attenuated vaccine within 8 weeks before registration
  • Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior registration or at any time during the study.
  • Positive serology defined by the following laboratory results:
  • Positive test for Human Immunodeficiency Virus (HIV)
  • Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening).
  • Patients with past / resolved Hepatitis B Virus (HBV) infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible, if HBV deoxyribonucleic acid (DNA) test is negative.
  • HBV DNA must be obtained in patients with positive hepatitis B core antibody prior start of study treatment.
  • Patients with active hepatitis C. Patients positive for Hepatitis C Virus (HCV) antibody are eligible only if Polymerase Chain Reaction (PCR) is negative for HCV ribonucleic acid (RNA).
  • Severe infections within 8 weeks prior registration including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia or signs or symptoms of infection requiring oral or IV antibiotics within 8 weeks prior registration.
  • Patients receiving routine antibiotic prophylaxis (e.g., to prevent chronic obstructive pulmonary disease exacerbation or for dental extraction) are eligible.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Treatment with systemic immunostimulatory agents (including but not limited to interferon (IFN)-alpha, interleukin (IL)-2 for any reason within 4 weeks or five half-lives of the drug, whichever is shorter, prior to registration.
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior registration.
  • Patients who are receiving acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) or physiologic replacement doses (i.e., prednisone 5-7.5 mg/day, or other) for adrenal insufficiency may be enrolled in the study.
  • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
  • TREATMENT ELIGIBILITY CRITERIA:
  • Treatment eligibility criteria will be assessed within 14 days before the vaccination period start. Patients are eligible to receive PEP-DC vaccination if they meet all the following criteria:
  • Key conditions required to initiate vaccination:
  • Confirmation from the CTE GMP laboratory that at least six doses of PEPDC vaccines have been produced and released, and are available for the patient at the CTE GMP facility.
  • Patient does not have any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that occurred since enrollment and that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 2 weeks of first vaccine injection:
  • Hemoglobin ≥ 90 g/L
  • Neutrophil count ≥ 1.0 G/L (independently of administration of growth factor within 4 weeks prior registration)
  • Platelet count ≥ 100 G/L
  • Serum creatinine, ≤ 1.5x Institutional Upper Limit of Normal (ULN), or Creatinine clearance (CrCl) ≥ 40 mL/min (calculated using the Cockcroft-Gault formula.
  • Serum bilirubin ≤ 1.5 ULN (except subjects with Gilbert's syndrome who must have a total bilirubin level of <3.0 x ULN)
  • AST/ALT ≤ 3 x ULN
  • Alkaline phosphatase ≤ 1.5 x ULN
  • Coagulation (INR, PT, aPTT): International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Progression since screening (confirmed by CT scan) according to RECIST 1.1
  • Production of vaccine was not successful (or less than 6 was produced)
  • Treatment with systemic immunosuppressive medications within 4 weeks prior vaccination (more than an equivalent of 10mg prednisone per day) except for premedication given for pemetrexed.
  • Any other diseases, cardiac, metabolic or other dysfunction, physical examination finding or clinical laboratory finding since the screening visit giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • CHUV Oncology Department

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: Phase Ib Study to Test the Feasibility and Safety of a Personalized Vaccine in Combination With Low-dose Cyclophosphamide in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

Phase Ib clinical trial using autologous dendritric cell (DC) vaccine loaded with personalized peptides (PEP) given in combination with low-dose cyclophosphamide, as standard of care (SOC) therapy in patients with advanced or recurrent metastatic NSCLC.

Read the detailed description

This is a Phase Ib, single center study evaluating safety and feasibility of DC vaccine (autologous monocyte-derived dendritic cells [moDCs] pulsed with personalized peptides [PEP-DC]) given in combination with low dose cyclophosphamide, as SOC therapy in patients with advanced or recurrent metastatic NSCLC.

Patients with advanced or metastatic NSCLC (metastatic, recurrent and/or unresectable) who received standard of care therapy for advanced disease with no signs of progression will be eligible for this protocol. Patients may have received any number of prior treatments without restriction and any prior immunotherapy before enrollment to the study. However, only patients receiving the maintenance/continuation of SOC treatment options mentioned below are permitted to enter the study. Patients will be enrolled in the following two cohorts:

  • Cohort 1: metastatic non-small cell lung cancer of any histology without any actionable oncogenic driver treated by SOC. Maintenance treatment with pemetrexed and/or maintenance/continuation of pembrolizumab, nivolumab or atezolizumab is allowed.
  • Cohort 2: metastatic NSCLC with actionable oncogenic driver such as Epidermal Growth Factor Receptors (EGFR) mutation, ROS Proto-Oncogene 1 Receptor Tyrosine Kinase (ROS-1) or anaplastic lymphoma kinase (ALK) rearrangement, currently receiving osimertinib, alectinib, lorlatinib, brigatinib or crizotinib as per SOC in each disease entity.

In both cohorts, patients will receive six DC vaccinations Q3W (±3 days) in combination with low dose cyclophosphamide the day before vaccination. Each dose of vaccine (PEP-DC) will be formulated in two syringes of 525 microL each and administered on week 2 day 2 (W2D2) of each cycle, as subcutaneous injections. Patients will be vaccinated until vaccine exhaustion, disease progression, major toxicity or patient withdrawal, whichever is earlier. Additional DC vaccines may be administered Q3W (±3 days) if available until vaccine exhaustion or disease progression, whichever is earlier.

Being tested
Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine), Low dose cyclophosphamide
Keywords
non-small cell lung cancer, vaccine, cyclophosphamide
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.

  • Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine)Biological

    Patients will receive six DC vaccinations Q3W (±3 days) in combination with low dose cyclophosphamide the day before vaccination.

    Each dose of vaccine (PEP-DC) will be split into two injections, which will be administered on W2D2 of each cycle, subcutaneously. Patients will be vaccinated until vaccine exhaustion, disease progression, major toxicity or patient withdrawal, whichever is earlier. Additional DC vaccines may be administered Q3W (±3 days) if available until vaccine exhaustion or disease progression, whichever is earlier.

  • Low dose cyclophosphamideDrug

    Patients will receive six DC vaccinations Q3W (±3 days) in combination with low dose cyclophosphamide the day before vaccination.

Study groups in NCT05195619
Study groupRoleWhat they receive
Cohort 1Experimentalmetastatic NSCLC of any histology without any actionable oncogenic driver treated by SOC. Maintenance treatment with pemetrexed and/or maintenance/continuation of pembrolizumab, nivolumab or atezolizumab is allowed.
Receives: Biological: Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine); Drug: Low dose cyclophosphamide
Cohort 2Experimentalmetastatic NSCLC with actionable oncogenic driver such as EGFR mutation, ROS-1 or ALK rearrangement, currently receiving osimertinib, alectinib, lorlatinib, brigatinib or crizotinib as per SOC in each disease entity.
Receives: Biological: Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine); Drug: Low dose cyclophosphamide

What is being measured

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

  1. Number of patients who receive at least one dose of vaccine

    Feasibility will be evaluated by the number of patients who receive at least one dose of vaccine, among all enrolled patients.

    Measured: 3.5 years after study activation

  2. Assessment of adverse events

    Safety will be assessed by recording all adverse events (AEs) observed from informed consent form (ICF) signature until 30 days after last injection of DC vaccine/cyclophosphamide.

    Measured: from informed consent form (ICF) signature until 30 days after last injection of DC vaccine/cyclophosphamide

  3. Assessment of treatment-limiting toxicities

    Collection of events defined as related to vaccine administration. Patients showing any of them will be withdrawn from the study.

    Measured: 21 days (i.e. during the full vaccination period)

Secondary outcomes (5)

  1. Overall response rate 1 (ORR1)

    Rate of patients with objective response (complete response or partial response) across all assessment time-points during the period from enrollment until 6 months.

    Measured: From enrollment until 6 months

  2. Overall response rate 2 (ORR2)

    Rate of patients with objective response (complete response or partial response) across all assessment time-points during the period from enrollment to progression of the disease (ORR2).

    Measured: From enrollment to progression of the disease (ORR2)

  3. Duration of response (DoR)

    Defined as the time from objective response (OR) until documented tumor progression date among responders.

    Measured: up to 2 years from 1st vaccine injection

  4. Progression-free survival (PFS)

    Defined as the time from enrollment until documented tumor progression date (as defined by RECIST v1.1). For patients without progression or death (or patients that withdraw or are lost to follow-up), censoring will occur at the last tumor assessment. PFS rate will be estimated at 6, 12 and 24 months.

    Measured: up to 2 years from 1st vaccine injection

  5. Overall survival (OS)

    Defined as the time from enrollment until death from any cause. Patients alive at the end of follow-up period will be censored at the last day the patient was known to be alive. OS survival rate will be estimated at 12 and 24 months after the date from first study treatment.

    Measured: up to 2 years from 1st vaccine injection

Timeline

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

  1. First posted19 Jan 2022
  2. Study start22 Mar 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A total of 16 evaluable patients will be recruited, eight in each cohort. Cohort 1: metastatic non-small cell lung cancer of any histology without any actionable oncogenic driver treated by SOC. Maintenance treatment with pemetrexed and/or maintenance/continuation of pembrolizumab, nivolumab or atezolizumab is allowed. Cohort 2: metastatic NSCLC with actionable oncogenic driver such as EGFR mutation, ROS-1 or ALK rearrangement, currently receiving osimertinib, alectinib, lorlatinib, brigatinib or crizotinib as per SOC in each disease entity.
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195619
Sponsor's protocol ID
CHUV-DO-0022-LUNGVAC-2019
Status last verified
Jul 2025
First submitted
17 Dec 2021
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine) and Low dose cyclophosphamide in people with Non-small Cell Lung Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 25 inclusion and 43 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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 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.

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?

Number of patients who receive at least one dose of vaccine (time frame: 3.5 years after study activation). The study lists 3 primary outcomes in all. 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 NCT05195619.

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 10 Jul 2025.

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