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

Primary Purpose

Non Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

neoantigen vaccine + EGFR-TKI

neoantigen vaccine + anti-angioge

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non-small cell lung cancer, Individualized neoantigen peptides vaccine, Targeted Drugs, clinical trial, phase I

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant and/or breastfeeding.
With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
Patients participated in other anticancer drug clinical trials within 4 weeks.
Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
Systemic infection.
Any uncertainties that have an impact on the safety or compliance of the patient.
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.

Sites / Locations

The First Hospital of ShijiazhuangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

neoantigen vaccine + EGFR-TKI

neoantigen vaccine + anti-angioge

Arm Description

Outcomes

Primary Outcome Measures

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

Safety

Secondary Outcome Measures

Progression-free Survival (PFS)

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

Overall survival (OS)

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

Disease Control Rate(DCR)

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

Full Information

NCT ID

NCT04487093

First Posted

July 23, 2020

Last Updated

July 24, 2020

Sponsor

First Hospital of Shijiazhuang City

Collaborators

Tianjin Hengjia Biotechnology Development co., LTD

1. Study Identification

Unique Protocol Identification Number

NCT04487093

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 17, 2020 (Actual)

Primary Completion Date

May 17, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Hospital of Shijiazhuang City

Collaborators

Tianjin Hengjia Biotechnology Development co., LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

neoantigen vaccine + EGFR-TKI

Arm Type

Experimental

Arm Title

neoantigen vaccine + anti-angioge

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

neoantigen vaccine + EGFR-TKI

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

neoantigen vaccine + anti-angioge

Intervention Description

neoantigen vaccine + anti-angioge

Primary Outcome Measure Information:

Title

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

Description

Safety

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

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

Time Frame

Up to 2 years

Title

Overall survival (OS)

Description

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

Time Frame

Up to 2 years

Title

Disease Control Rate(DCR)

Description

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

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV). With EGFR-TKI sensitive mutations and no T790M. First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months and there is no disease progression. Patients aged 18 to 85 Life expectancy of at least 3 months. ECOG Performance Status 0 to 3. No previous immunotherapy, including anti-PD-1/PD-L1 or co-suppressive T cell receptor drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy. Ability to follow research and follow-up procedures. Able to understand and willing to sign an IRB approved written informed consent document. Exclusion Criteria: Pregnant and/or breastfeeding. With active, known or suspected autoimmune diseases or other concurrent immune system diseases. Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs. Patients participated in other anticancer drug clinical trials within 4 weeks. Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function. Systemic infection. Any uncertainties that have an impact on the safety or compliance of the patient. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Zhang, M.D.

Phone

17603119607

13315978836@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Zhang, M.D.

Organizational Affiliation

The First Hospital of Shijiazhuang

Official's Role

Study Chair

Facility Information:

Facility Name

The First Hospital of Shijiazhuang

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan Zhang, M.D.

Phone

17603119607

Ext

+86

13315978836@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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