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

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ClinicalTrials.gov Identifier: NCT04487093
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Collaborator:
Tianjin Hengjia Biotechnology Development co., LTD
Information provided by (Responsible Party):
YAN ZHANG, First Hospital of Shijiazhuang City

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: neoantigen vaccine + EGFR-TKI Drug: neoantigen vaccine + anti-angioge Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients enrolled without disease progression were given neoantigen vaccine combined with EGFR-TKI therapy; Patients with disease progression were given neoantigen vaccine combined with anti-angiogenesis drug therapy. Patients received subcutaneous injection of individualized neoantigen vaccines 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Personalized Neoantigen Peptide Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer
Actual Study Start Date : May 17, 2020
Estimated Primary Completion Date : May 17, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: neoantigen vaccine + EGFR-TKI Drug: neoantigen 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.


Experimental: neoantigen vaccine + anti-angioge Drug: neoantigen vaccine + anti-angioge
neoantigen vaccine + anti-angioge




Primary Outcome Measures :
  1. Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. [ Time Frame: 24 months ]
    Safety


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]
    PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

  2. Overall survival (OS) [ Time Frame: Up to 2 years ]
    OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

  3. Disease Control Rate(DCR) [ Time Frame: Up to 12 weeks ]
    DCR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487093


Contacts
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Contact: Yan Zhang, M.D. 17603119607 13315978836@163.com

Locations
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China, Hebei
The First Hospital of Shijiazhuang Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Yan Zhang, M.D.    17603119607 ext +86    13315978836@163.com   
Sponsors and Collaborators
First Hospital of Shijiazhuang City
Tianjin Hengjia Biotechnology Development co., LTD
Investigators
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Study Chair: Yan Zhang, M.D. The First Hospital of Shijiazhuang
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Responsible Party: YAN ZHANG, Director of Oncology IV, First Hospital of Shijiazhuang City
ClinicalTrials.gov Identifier: NCT04487093    
Other Study ID Numbers: DYYY-2020-04-01
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YAN ZHANG, First Hospital of Shijiazhuang City:
non-small cell lung cancer
Individualized neoantigen peptides vaccine
Targeted Drugs
clinical trial
phase I
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs