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Trial Title:
Efficacy and Safety of Neoantigen Peptide Vaccine in the Treatment of Advanced NSCLC Progressed After EGFR-TKI Treatment
NCT ID:
NCT06095934
Condition:
NSCLC
EGFR Gene Mutation
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
neo-antigen vaccine
Description:
anti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy
Arm group label:
Evaluate the efficacy and safety of neo-antigen peptide vaccine in the treatment of advanced NSCLC
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient voluntarily joined this study and signed an informed consent form;
2. ≥ 18 years old, both male and female;
3. 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);
4. Metastatic advanced EGFR mutated lung cancer confirmed by histology or cytology,
with EGFR-TKI monotherapy or EGFR-TKI combined anti angiogenic therapy failing;
5. Patients who have received first-line chemotherapy in the past can be included in
the inclusion criteria;
6. ECOG score: 0-2;
7. Expected survival time ≥ 12 weeks;
8. 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;
9. 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);
10. 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;
11. Agree to provide blood samples and histological specimens.
Exclusion Criteria:
1. The patient has any active autoimmune disease or a history of autoimmune disease;
2. The patient is currently using immunosuppressive agents or systemic hormone therapy
to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other
therapeutic hormones) ;
3. The patient experienced severe allergic reactions to other monoclonal antibodies;
4. Suffering from hypertension and unable to achieve good control through
antihypertensive medication treatment (systolic blood pressure ≥ 140mmHg or
diastolic blood pressure ≥ 90mmHg);
5. 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);
6. 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;
7. Received previous anti-tumor immunotherapy and anti-tumor vaccine treatment;
8. 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;
9. 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;
10. The patient has previously received anti PD-1, anti PD-L1, and anti PD-L2 treatment;
11. Those who are known to be allergic to the components of recombinant humanized
anti-PD-1 monoclonal antibody drugs and vaccines;
12. Pregnant or lactating women, or female patients with fertility who have not taken
contraceptive measures;
13. 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;
14. Patients who participate in other clinical trials at the same time;
15. HIV positive; HCV positive; Uncontrolled active hepatitis B;
16. Those who have received live vaccination within 4 weeks before the start of
treatment;
17. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Medical School of Nanjing University & Clinical Center Institute of Nanjing University, Nanjing, China
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Shu Su
Phone:
02583106666
Email:
ssnine@126.com
Start date:
March 1, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095934
