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Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant 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), with disease progression after surgery and standard chemotherapy. 2. With EGFR-TKI sensitive mutations and progresses after receiving EGFR-TKI treatment. 3. The first neoantigen treatment is more than 4 weeks away from the previous chemotherapy or clinical research drug treatment. 4. The first neoantigen treatment is more than 4 weeks away from the previous radiotherapy or EGFR-TKI treatment. 5. At least one measurable disease according to RECIST v1.1. 6. 18 years of age or older. 7. Life expectancy of at least 3 months. 8. ECOG Performance Status 0 or 1. 9. Have adequate organ function, as measured by laboratory values: Lymphocyte ratio>20%; WBC>3.0×10^9/L; alanine aminotransferase(ALT) and aspartate aminotransferase (AST)≤2.5 × ULN; If the patient has liver metastases, ALT and AST≤5 × ULN; Alkaline phosphatase(ALP)≤2.5 × ULN; total serum bilirubin (TBIL) < 1.5 × ULN; Urea nitrogen(BUN)≤1.5 × ULN; Creatinine(Cr)≤ULN; Normal blood coagulation function, urine routine, and electrocardiogram (ECG). 10. Available tumor specimen for sequencing and EGFR gene mutation frequency>5%. 11. Ability to find more than 3 available neoantigen epitopes. 12. No previous immunotherapy, including anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or targeting another stimulatory or co-suppressive T cell receptor (eg CTLA-4, OX-40, CD137 ) drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy. 13. Ability to follow research and follow-up procedures. 14. Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

1. Suffering from other known malignant tumors, which are progressing or require active treatment within the past 5 years. 2. History of immunodeficiency disorder or autoimmune condition requiring active immunosuppressive therapy. 3. Actively infectious condition including hepatitis; HIV antibody positive; Treponema pallidum antibody positive. 4. With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. 5. Known, active, untreated CNS metastasis and / or cancerous meningitis. 6. Mental illness or substance abuse disorder, which will interfere with the cooperation with research requirements. 7. Evidence of Liver and kidney dysfunction, severe heart disease, coagulation dysfunction and damage to hematopoietic function. 8. Receive systemic cytotoxic chemotherapy or test drugs for metastatic NSCLC (excluding EGFR-TKI) within the past month. 9. Receive radiotherapy within 2 weeks before the start of neoantigen treatment or chemotherapy within 4 weeks. Participants must recover from all radiochemotherapy-related toxicity without the use of corticosteroids and have not had radiation pneumonitis. Palliative radiotherapy allowed for symptom control must be completed at least 2 weeks before the first medication, and no additional radiotherapy is planned for the same lesion. 10. Patients participated in other anticancer drug clinical trials within 4 weeks. 11. A psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record or the investigator believes that there are other reasons that are not suitable for inclusion. 12. Pregnant and/or breastfeeding.

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.

NCT04397926
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.

Sun Yat-sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Li Zhang, M.D.
Principal Investigator Affiliation Sun Yat-sen University
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 peptides 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

Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks

Interventions

Drug: - Individualized neoantigen peptides vaccine

Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks

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

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060

Site Contact

Li Zhang, M.D.

[email protected]

86-20-8734-3894