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

NCT ID: NCT04397926

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-30
• Study Completion Date: 2022-12-30

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.

Detailed Description

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neoantigen vaccine

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

Group Type: EXPERIMENTAL

Individualized neoantigen peptides vaccine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

HJ-N-001

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Hengjia Biotechnology Development co., LTD

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang, MD

Director of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Zhang, M.D.

Role: CONTACT

zhangli@sysucc.org.cn

86-20-8734-3894

Facility Contacts

Li Zhang, M.D.

Role: primary

zhangli@sysucc.org.cn

86-20-8734-3894

Other Identifiers

Neo-Peptide2020

Identifier Type: -

Identifier Source: org_study_id