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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-17

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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neoantigen vaccine + EGFR-TKI

Group Type EXPERIMENTAL

neoantigen vaccine + EGFR-TKI

Intervention Type DRUG

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.

neoantigen vaccine + anti-angioge

Group Type EXPERIMENTAL

neoantigen vaccine + anti-angioge

Intervention Type DRUG

neoantigen vaccine + anti-angioge

Interventions

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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.

Intervention Type DRUG

neoantigen vaccine + anti-angioge

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No