Status:
UNKNOWN
Clinical Study of Neoantigen Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer
Lead Sponsor:
First Hospital of Shijiazhuang City
Collaborating Sponsors:
Tianjin Hengjia Biotechnology Development co., LTD
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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 adv...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04487093
Start Date
May 17 2020
End Date
December 1 2022
Last Update
July 27 2020
Active Locations (1)
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1
The First Hospital of Shijiazhuang
Shijiazhuang, Hebei, China, 050000