Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer

NCT04397926 | Unknown Phase 1

• 1 other identifier: Neo-Peptide2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

neoantigen peptides vaccine，non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Safety of the neoantigen vaccine treatment.

  Adverse events occurring after the neoantigen vaccine treatment are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

  24 months

Study Arms (1)

neoantigen vaccine

EXPERIMENTAL

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

Drug: Individualized neoantigen peptides vaccine

Interventions

Individualized neoantigen peptides vaccine DRUG

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

Also known as: HJ-N-001

neoantigen vaccine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV), with disease progression after surgery and standard chemotherapy.
• With EGFR-TKI sensitive mutations and progresses after receiving EGFR-TKI treatment.
• The first neoantigen treatment is more than 4 weeks away from the previous chemotherapy or clinical research drug treatment.
• The first neoantigen treatment is more than 4 weeks away from the previous radiotherapy or EGFR-TKI treatment.
• At least one measurable disease according to RECIST v1.1.
• years of age or older
• Life expectancy of at least 3 months.
• ECOG Performance Status 0 or 1.
• 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).
• Available tumor specimen for sequencing and EGFR gene mutation frequency\>5%.
• Ability to find more than 3 available neoantigen epitopes.
• 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.
• Ability to follow research and follow-up procedures.
• Able to understand and willing to sign an IRB approved written informed consent document.

You may not qualify if:

• Suffering from other known malignant tumors, which are progressing or require active treatment within the past 5 years.
• History of immunodeficiency disorder or autoimmune condition requiring active immunosuppressive therapy.
• Actively infectious condition including hepatitis; HIV antibody positive; Treponema pallidum antibody positive.
• With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
• Known, active, untreated CNS metastasis and / or cancerous meningitis.
• Mental illness or substance abuse disorder, which will interfere with the cooperation with research requirements.
• Evidence of Liver and kidney dysfunction, severe heart disease, coagulation dysfunction and damage to hematopoietic function.
• Receive systemic cytotoxic chemotherapy or test drugs for metastatic NSCLC (excluding EGFR-TKI) within the past month.
• 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.
• Patients participated in other anticancer drug clinical trials within 4 weeks
• Pregnant and/or breastfeeding.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Tianjin Hengjia Biotechnology Development co., LTD: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, M.D.

CONTACT

86-20-8734-3894; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oncology

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

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: May 30, 2020
• Primary Completion: May 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CN (1)