Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Individualized neoantigen peptides vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring neoantigen peptides vaccine,non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
- 18 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.
Exclusion Criteria:
- 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
- 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.
- Pregnant and/or breastfeeding.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neoantigen vaccine
Arm Description
Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04397926
First Posted
May 18, 2020
Last Updated
June 10, 2020
Sponsor
Sun Yat-sen University
Collaborators
Tianjin Hengjia Biotechnology Development co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT04397926
Brief Title
Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
Official Title
Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Tianjin Hengjia Biotechnology Development co., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
neoantigen peptides vaccine,non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neoantigen vaccine
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Individualized neoantigen peptides vaccine
Other Intervention Name(s)
HJ-N-001
Intervention Description
Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks
Primary Outcome Measure Information:
Title
Safety of the neoantigen vaccine treatment.
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
18 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.
Exclusion Criteria:
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
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.
Pregnant and/or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhang, M.D.
Phone
86-20-8734-3894
Email
zhangli@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang, M.D.
Phone
86-20-8734-3894
Email
zhangli@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
We'll reach out to this number within 24 hrs