NSCLCNCT06095934
Efficacy and Safety of Neoantigen Peptide Vaccine in the Treatment of Advanced NSCLC Progressed After EGFR-TKI Treatment
A study testing neo-antigen vaccine in people with NSCLC and EGFR Gene Mutation, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
To evaluate the efficacy (ORR) and safety of anti PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy in the treatment of advanced NSCLC progressed after EGFR-TKI treatment and to provide new treatment methods for EGFR-TKI resistant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, EGFR Gene Mutation
- What is being tested?
- neo-antigen vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily joined this study and signed an informed consent form;
- ≥ 18 years old, both male and female;
- Pathologically confirmed IIIB-IV stage NSCLC, with at least one measurable lesion that has not undergone local treatment (according to RECIST v1.1, the length of the measurable lesion on spiral CT or MRI scans is ≥ 10 mm or the short diameter of the enlarged lymph node is ≥ 15 mm);
- Metastatic advanced EGFR mutated lung cancer confirmed by histology or cytology, with EGFR-TKI monotherapy or EGFR-TKI combined anti angiogenic therapy failing;
- Patients who have received first-line chemotherapy in the past can be included in the inclusion criteria;
- ECOG score: 0-2;
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- Expected survival time ≥ 12 weeks;
- The functions of important organs meet the following requirements:Absolute neutrophil count ≥ 1.5 × 109/L;Absolute lymphocyte count ≥ 0.8 × 109/L;Platelets ≥ 80 × 109/L;Hemoglobin ≥ 90g/L;Bilirubin ≤ 1.5 × ULN (within 7 days before the first medication);ALT and AST ≤ 1.5 × ULN (within 7 days before the first medication); Serum creatinine ≤ 1.5 × ULN;
- Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously, and if FT3 and FT4 levels are normal, they can be included in the group level);
- For female patients of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last administration of treatment medication;
- Agree to provide blood samples and histological specimens.
Who cannot join
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones) ;
- The patient experienced severe allergic reactions to other monoclonal antibodies;
- Suffering from hypertension and unable to achieve good control through antihypertensive medication treatment (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as:NYHA grade 2 or above heart failure;Unstable angina pectoris; Have experienced myocardial infarction within 1 year;Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; QTc>450ms (male); QTc>470ms (female);
- Abnormal coagulation function (INR>2.0, PT>16s), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment, allowing prophylactic use of low-dose aspirin and low molecular weight heparin;
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- Received previous anti-tumor immunotherapy and anti-tumor vaccine treatment;
- The patient has active infection, unexplained fever ≥ 38.5 ° C within 7 days before medication, or baseline white blood cell count>15 × 109/L; Those who may have purulent or chronic infections, and the wound persists without healing;
- Patients who have experienced bone metastasis have received palliative radiotherapy in areas greater than 5% of the bone marrow area within the 4 weeks prior to participating in this study;
- The patient has previously received anti PD-1, anti PD-L1, and anti PD-L2 treatment;
- Those who are known to be allergic to the components of recombinant humanized anti-PD-1 monoclonal antibody drugs and vaccines;
- Pregnant or lactating women, or female patients with fertility who have not taken contraceptive measures;
- Other malignant tumors (excluding basal cell or squamous cell carcinoma, superficial bladder cancer cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;
- Patients who participate in other clinical trials at the same time;
- HIV positive; HCV positive; Uncontrolled active hepatitis B;
- Those who have received live vaccination within 4 weeks before the start of treatment;
- Patients with a history of asymptomatic brain metastasis who meet all the following conditions can be selected:During screening, brain imaging showed no evidence of immediate progression.There is currently no need to use glucocorticoids to treat brain metastases, and stable doses of anticonvulsants are allowed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Medical School of Nanjing University & Clinical Center Institute of Nanjing University, Nanjing, China
Nanjing
Shu Su, 02583106666, ssnine@126.com
About this study
Official title: Exploration of the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined With Neoantigen Peptide Vaccine and Chemotherapy in the Treatment of Advanced NSCLC Progressed After EGFR-TKI Treatment
To evaluate the efficacy (ORR) and safety of anti PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy in the treatment of advanced NSCLC progressed after EGFR-TKI treatment and to provide new treatment methods for EGFR-TKI resistant patients.
- Conditions
- NSCLC, EGFR Gene Mutation
- Being tested
- neo-antigen vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neo-antigen vaccineOther
anti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Evaluate the efficacy and safety of neo-antigen peptide vaccine in the treatment of advanced NSCLC | Experimental | Not described Receives: Other: neo-antigen vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Exploration of the efficacy of anti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy in the treatment of advanced NSCLC with previous EGFR-TKI treatment failure
Measured: three years
Secondary outcomes (2)
PFS
Observe and evaluate the progression free survival (PFS), overal survival(OS) of advanced NSCLC patients who have failed previous EGFR-TKI treatment with anti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy;
Measured: three years
OS
Observe and evaluate the overal survival(OS) of advanced NSCLC patients who have failed previous EGFR-TKI treatment with anti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy;
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Mar 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095934
- Sponsor's protocol ID
- NEOVAC-BGB-C
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined With Neoantigen Peptide Vaccine and Chemotherapy in the Treatment of Advanced NSCLC Progressed After EGFR-TKI Treatment
- ClinicalTrials.gov ID
- NCT06095934
- Acronym / sponsor ID
- NEOVAC-BGB-C
- Conditions
- NSCLC, EGFR Gene Mutation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
To evaluate the efficacy (ORR) and safety of anti PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy in the treatment of advanced NSCLC progressed after EGFR-TKI treatment and to provide new treatment methods for EGFR-TKI resistant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluate the efficacy and safety of neo-antigen peptide vaccine in the treatment of advanced NSCLC | Experimental | Other: neo-antigen vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient voluntarily joined this study and signed an informed consent form;
- ≥ 18 years old, both male and female;
- Pathologically confirmed IIIB-IV stage NSCLC, with at least one measurable lesion that has not undergone local treatment (according to RECIST v1.1, the length of the measurable lesion on spiral CT or MRI scans is ≥ 10 mm or the short diameter of the enlarged lymph node is ≥ 15 mm);
- Metastatic advanced EGFR mutated lung cancer confirmed by histology or cytology, with EGFR-TKI monotherapy or EGFR-TKI combined anti angiogenic therapy failing;
- Patients who have received first-line chemotherapy in the past can be included in the inclusion criteria;
Key exclusion criteria (17 listed)
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones) ;
- The patient experienced severe allergic reactions to other monoclonal antibodies;
- Suffering from hypertension and unable to achieve good control through antihypertensive medication treatment (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as:NYHA grade 2 or above heart failure;Unstable angina pectoris; Have experienced myocardial infarction within 1 year;Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; QTc>450ms (male); QTc>470ms (female);
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 |
|---|---|---|
| neo-antigen vaccineanti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy | Other | Evaluate the efficacy and safety of neo-antigen peptide vaccine in the treatment of advanced NSCLC |
Primary outcome
ORR
Time frame: three years
Exploration of the efficacy of anti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy in the treatment of advanced NSCLC with previous EGFR-TKI treatment failure
2 secondary outcomes
PFS
Time frame: three years
OS
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neo-antigen vaccine in people with NSCLC and EGFR Gene Mutation, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 11 inclusion and 17 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 23 Oct 2023. 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.
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 Baorui Liu, MD,PhD (02583106666, baoruiliu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: three years). 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 23 Oct 2023.