Non Small Cell Lung CancerPhase 1NCT04487093
Clinical Study of Neoantigen Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer
A Phase 1 study testing neoantigen vaccine + EGFR-TKI and neoantigen vaccine + anti-angioge in people with Non Small Cell Lung Cancer, run by First Hospital of Shijiazhuang City 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?
- neoantigen vaccine + EGFR-TKI and neoantigen vaccine + anti-angioge
- 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
- 17 May 2020to 1 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 EGFR-TKI sensitive mutations and no T790M.
- First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months and there is no disease progression.
- Patients aged 18 to 85
- Life expectancy of at least 3 months.
- ECOG Performance Status 0 to 3.
- No previous immunotherapy, including anti-PD-1/PD-L1 or co-suppressive T cell receptor 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
- Pregnant and/or breastfeeding.
- With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
- Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
- Patients participated in other anticancer drug clinical trials within 4 weeks.
- Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
- Systemic infection.
- Any uncertainties that have an impact on the safety or compliance of the patient.
- Any disease, treatment, abnormal laboratory history or medical history that affects the participant's participation in the entire research process, or the investigator believes that it is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Shijiazhuang
Shijiazhuang, Hebei, 050000
Yan Zhang, M.D., 17603119607 ext. +86, 13315978836@163.com
About this study
Official title: Clinical Study of Personalized Neoantigen Peptide Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer
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 peptide vaccine combined with targeted drugs 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
- neoantigen vaccine + EGFR-TKI, neoantigen vaccine + anti-angioge
- Keywords
- non-small cell lung cancer, Individualized neoantigen peptides vaccine, Targeted Drugs, clinical trial, phase I
- 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.
neoantigen vaccine + EGFR-TKIDrug
Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 5 weeks.
The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.
neoantigen vaccine + anti-angiogeDrug
neoantigen vaccine + anti-angioge
| Study group | Role | What they receive |
|---|---|---|
| neoantigen vaccine + EGFR-TKI | Experimental | Not described Receives: Drug: neoantigen vaccine + EGFR-TKI |
| neoantigen vaccine + anti-angioge | Experimental | Not described Receives: Drug: neoantigen vaccine + anti-angioge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
Safety
Measured: 24 months
Secondary outcomes (3)
Progression-free Survival (PFS)
PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
Measured: Up to 2 years
Overall survival (OS)
OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
Measured: Up to 2 years
Disease Control Rate(DCR)
DCR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start17 May 2020
- Primary completion17 May 2022 (estimated)
- Study completion1 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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled without disease progression were given neoantigen vaccine combined with EGFR-TKI therapy； Patients with disease progression were given neoantigen vaccine combined with anti-angiogenesis drug therapy. Patients received subcutaneous injection of individualized neoantigen vaccines at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of Shijiazhuang City
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Hengjia Biotechnology Development co., LTD
- Responsible party
- Principal investigator, YAN ZHANG, First Hospital of Shijiazhuang City
- Investigators
- Yan Zhang, M.D., Study chair, The First Hospital of Shijiazhuang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487093
- Sponsor's protocol ID
- DYYY-2020-04-01
- Status last verified
- May 2020
- First submitted
- 23 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Personalized Neoantigen Peptide Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04487093
- Acronym / sponsor ID
- DYYY-2020-04-01
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, Individualized neoantigen peptides vaccine, Targeted Drugs, clinical trial, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Hospital of Shijiazhuang CityUniversity, hospital or other
- Collaborators
- Tianjin Hengjia Biotechnology Development co., LTD
- Study start
- 17 May 2020 (actual)
- Primary completion
- 17 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 27 Jul 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 peptide vaccine combined with targeted drugs 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients enrolled without disease progression were given neoantigen vaccine combined with EGFR-TKI therapy； Patients with disease progression were given neoantigen vaccine combined with anti-angiogenesis drug therapy. Patients received subcutaneous injection of individualized neoantigen vaccines at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance.
| Arm | Type | Receives |
|---|---|---|
| neoantigen vaccine + EGFR-TKI | Experimental | Drug: neoantigen vaccine + EGFR-TKI |
| neoantigen vaccine + anti-angioge | Experimental | Drug: neoantigen vaccine + anti-angioge |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV).
- With EGFR-TKI sensitive mutations and no T790M.
- First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months and there is no disease progression.
- Patients aged 18 to 85
- Life expectancy of at least 3 months.
Key exclusion criteria (8 listed)
- Pregnant and/or breastfeeding.
- With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
- Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
- Patients participated in other anticancer drug clinical trials within 4 weeks.
- Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
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 |
|---|---|---|
| neoantigen vaccine + EGFR-TKIPatients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 5 weeks. The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance. | Drug | neoantigen vaccine + EGFR-TKI |
| neoantigen vaccine + anti-angiogeneoantigen vaccine + anti-angioge | Drug | neoantigen vaccine + anti-angioge |
Primary outcome
Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
Time frame: 24 months
Safety
3 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Disease Control Rate(DCR)
Time frame: Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Yan Zhang, M.D. study chair
The First Hospital of Shijiazhuang
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 neoantigen vaccine + EGFR-TKI and neoantigen vaccine + anti-angioge in people with Non Small Cell Lung Cancer, run by First Hospital of Shijiazhuang City 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 8 inclusion and 8 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 27 Jul 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 Yan Zhang, M.D. (17603119607, 13315978836@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. (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 27 Jul 2020.