Non Small Cell Lung CancerPhase 1NCT04397926
Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
A Phase 1 study testing Individualized neoantigen peptides vaccine in people with Non Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Individualized neoantigen peptides vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2020to 30 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, M.D., 86-20-8734-3894, zhangli@sysucc.org.cn
About this study
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.
Read the 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
- Being tested
- Individualized neoantigen peptides vaccine
- Keywords
- neoantigen peptides vaccine，non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized neoantigen peptides vaccineDrug
Also called HJ-N-001
Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Individualized neoantigen peptides vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start30 May 2020
- Primary completion30 May 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Hengjia Biotechnology Development co., LTD
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
- Investigators
- Li Zhang, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397926
- Sponsor's protocol ID
- Neo-Peptide2020
- Status last verified
- Jun 2020
- First submitted
- 18 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04397926
- Acronym / sponsor ID
- Neo-Peptide2020
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- neoantigen peptides vaccine，non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Tianjin Hengjia Biotechnology Development co., LTD
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| neoantigen vaccine | Experimental | Drug: Individualized neoantigen peptides vaccinePatients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized neoantigen peptides vaccineAlso: HJ-N-001Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks | Drug | neoantigen vaccine |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Individualized neoantigen peptides vaccine in people with Non Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, M.D. (86-20-8734-3894, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the neoantigen vaccine treatment. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.