- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04397926
Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
June 10, 2020 updated by: Li Zhang, MD, Sun Yat-sen University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li Zhang, M.D.
- Phone Number: 86-20-8734-3894
- Email: zhangli@sysucc.org.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- Li Zhang, M.D.
- Phone Number: 86-20-8734-3894
- Email: zhangli@sysucc.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the neoantigen vaccine treatment.
Time Frame: 24 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Li Zhang, M.D., Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2020
Primary Completion (Anticipated)
May 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
May 18, 2020
First Submitted That Met QC Criteria
May 18, 2020
First Posted (Actual)
May 21, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 10, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neo-Peptide2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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