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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04487093
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	First Hospital of Shijiazhuang City
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yan Zhang, M.D.
Principal Investigator Affiliation	The First Hospital of Shijiazhuang
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Non Small Cell Lung Cancer

Additional Details

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.

Arms & Interventions

Arms

Experimental: neoantigen vaccine + EGFR-TKI

Experimental: neoantigen vaccine + anti-angioge

Interventions

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.

Drug: - neoantigen vaccine + anti-angioge

neoantigen vaccine + anti-angioge

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The First Hospital of Shijiazhuang, Shijiazhuang, Hebei, China

Status

Recruiting

Address

The First Hospital of Shijiazhuang

Shijiazhuang, Hebei, 050000

Site Contact

Yan Zhang, M.D.

[email protected]

17603119607 #+86

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