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Efficacy and Safety of Neoantigen Peptide Vaccine in the Treatment of Advanced NSCLC Progressed After EGFR-TKI Treatment

Primary Purpose

NSCLC, EGFR Gene Mutation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
neo-antigen vaccine
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Medical School of Nanjing University & Clinical Center Institute of Nanjing University, Nanjing, ChinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluate the efficacy and safety of neo-antigen peptide vaccine in the treatment of advanced NSCLC

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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;
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;

Full Information

First Posted
September 7, 2023
Last Updated
October 19, 2023
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT06095934
Brief Title
Efficacy and Safety of Neoantigen Peptide Vaccine in the Treatment of Advanced NSCLC Progressed After EGFR-TKI Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC, EGFR Gene Mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evaluate the efficacy and safety of neo-antigen peptide vaccine in the treatment of advanced NSCLC
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
neo-antigen vaccine
Intervention Description
anti-PD-1 monoclonal antibody combined with neoantigen peptide vaccine and chemotherapy
Primary Outcome Measure Information:
Title
ORR
Description
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
Time Frame
three years
Secondary Outcome Measure Information:
Title
PFS
Description
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;
Time Frame
three years
Title
OS
Description
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;
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baorui Liu, MD,PhD
Phone
02583106666
Email
baoruiliu@nju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lifeng Wang, MD,PhD
Phone
02583106666
Email
lifengwang@nju.edu.cn
Facility Information:
Facility Name
The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Medical School of Nanjing University & Clinical Center Institute of Nanjing University, Nanjing, China
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Su
Phone
02583106666
Email
ssnine@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Neoantigen Peptide Vaccine in the Treatment of Advanced NSCLC Progressed After EGFR-TKI Treatment

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