CClinicalTrials.gg
Sign In
Status unknownNCT04487093Updated Jul 27, 2020

Clinical Study of Neoantigen Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer

A Phase 1 interventional study of neoantigen vaccine + EGFR-TKI and neoantigen vaccine + anti-angioge in Non Small Cell Lung Cancer, sponsored by First Hospital of Shijiazhuang City. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-07-27.

Sponsored by First Hospital of Shijiazhuang City · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have been conducted with success on Melanoma and glioblastoma. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV) and EGFR mutant non-small cell lung cancer will be resistant after targeted drug treatment. Neoantigen vaccine is a new treatment method for lung cancer, especially for patients with drug resistance.

Read the detailed description

This is a phase I clinical study of individualized neoantigen peptide vaccine combined with targeted drugs in the treatment of EGFR mutant non-small cell lung cancer aimed to evaluated the safety and immune response of the neoantigen vaccine treatment.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • non-small cell lung cancer
  • Individualized neoantigen peptides vaccine
  • Targeted Drugs
  • clinical trial
  • phase I
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

First Hospital of Shijiazhuang City is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV).
  2. With EGFR-TKI sensitive mutations and no T790M.
  3. First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months and there is no disease progression.
  4. Patients aged 18 to 85
  5. Life expectancy of at least 3 months.
  6. ECOG Performance Status 0 to 3.
  7. No previous immunotherapy, including anti-PD-1/PD-L1 or co-suppressive T cell receptor drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy.
  8. Ability to follow research and follow-up procedures. Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant and/or breastfeeding.
  2. With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
  3. Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
  4. Patients participated in other anticancer drug clinical trials within 4 weeks.
  5. Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
  6. Systemic infection.
  7. Any uncertainties that have an impact on the safety or compliance of the patient.
  8. Any disease, treatment, abnormal laboratory history or medical history that affects the participant's participation in the entire research process, or the investigator believes that it is not suitable to participate in this study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    neoantigen vaccine + EGFR-TKI

    Drug: neoantigen vaccine + EGFR-TKI

  • Experimental
    neoantigen vaccine + anti-angioge

    Drug: neoantigen vaccine + anti-angioge

Interventions

  • Drugneoantigen vaccine + EGFR-TKI

    Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.

  • Drugneoantigen vaccine + anti-angioge

    neoantigen vaccine + anti-angioge

06

What researchers measure

Primary outcomes

  1. Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

    Safety

    Time frame: 24 months

Secondary outcomes

  1. Progression-free Survival (PFS)

    PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

    Time frame: Up to 2 years

  2. Overall survival (OS)

    OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

    Time frame: Up to 2 years

  3. Disease Control Rate(DCR)

    DCR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

    Time frame: Up to 12 weeks

07

Study locations

1 of 1 sites recruiting
  • The First Hospital of Shijiazhuang
    Shijiazhuang, Hebei 050000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04487093
Lead sponsor
First Hospital of Shijiazhuang City
Collaborators
Tianjin Hengjia Biotechnology Development co., LTD
Responsible party
YAN ZHANG (Director of Oncology IV, First Hospital of Shijiazhuang City) — Principal investigator
First posted
Jul 27, 2020
Start date
May 17, 2020
Primary completion
May 17, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Jul 27, 2020

Study contacts

Yan Zhang, M.D.
Contact
13315978836@163.com
17603119607
Yan Zhang, M.D.
study chair · The First Hospital of Shijiazhuang

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

First Hospital of Shijiazhuang City

Start the discussion