Actively Recruiting
A Multicenter Study of Personalized Tumor Neoantigen-based Peptide Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment
Led by The First Affiliated Hospital of Nanchang University · Updated on 2024-12-30
10
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment approach for patients with advanced non-small cell lung cancer (NSCLC) who have progressed after first-line treatment. This study aims to assess the effectiveness and safety of a personalized tumor neoantigen-based peptide vaccine combined with a PD-1 inhibitor and radiotherapy. Key outcomes include objective response rate, disease control rate, adverse events, progression-free survival, and overall survival. Participants will receive a personalized radiotherapy course followed by PD-1 inhibitor injections every three weeks. Alongside, they will be given 10 subcutaneous injections of the personalized vaccine over a 21-week treatment period. The vaccine administration is divided into a primary phase with six treatments spaced weekly and biweekly, and a boost phase with four treatments spaced three weeks apart. During the study, participants will undergo regular follow-up visits every six weeks until the study ends, including blood collection, physical exams, performance status assessments, imaging scans (CT/MRI and X-rays), and laboratory tests. Researchers will monitor treatment response, safety, and survival outcomes over an average of 30 weeks, with progression-free and overall survival assessed up to 66 months. The total study duration supports comprehensive evaluation of the treatment combination.
CONDITIONS
Brief Title
Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed advanced NSCLC requiring radiotherapy for metastatic lesions
- At least one measurable lesion
- Aged 18 to 70 years, any gender
- Disease progression after standard first-line therapy and more than 2 weeks since last antitumor treatment
- Expected survival of at least 3 months
- ECOG performance status of 0-1
- Female patients of childbearing age with negative pregnancy test and able to use effective contraception for 6 months
- Able to undergo all required screening laboratory tests
- Normal major organ function including heart, liver, and kidney
- Adequate hematologic parameters as specified
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel within specified limits
- Thyroid function tests within specified limits
- Adrenocorticotropic hormone within 1.1-17.6 pmol/L
- Ability to understand and voluntarily sign informed consent form
You will not qualify if you...
- Uncontrollable brain metastases
- Expected to require any antitumor treatment during the study including maintenance therapy, chemotherapy, or surgery
- Systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressants within 14 days before first dose (inhalational or topical corticosteroids allowed without active autoimmune disease)
- Treatment with anticancer immunotherapies or immunostimulatory drugs within 3 months before first dose
- Participation in other clinical trials or less than 4 weeks since last dose in previous trial
- Severe cardiovascular diseases including NYHA Class II or higher, recent myocardial infarction or cerebrovascular accidents within 3 months, unstable arrhythmias or angina within 1 month
- Uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias
- Hypertension not controlled by medication (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- Significant bleeding symptoms or high risk of major bleeding
- Arterial or venous thrombotic events within 3 months before screening
- Active tuberculosis or serious infection within 4 weeks before first dose
- Tissue or organ transplantation history or preparation
- Uncontrolled epilepsy, central nervous system disorders, or neurological diseases causing cognitive impairment
- History of splenectomy
- Pregnant or breastfeeding women
- Severe allergy history or atopic constitution
- History of chronic alcohol or drug abuse within 6 months
- Deemed unsuitable for study by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by participant according to treatment plan
Participants receive a personalized radiotherapy treatment course designed by their doctor based on their condition.
Number of visits varies depending on radiotherapy schedule
Duration - 21 weeks
After radiotherapy, participants receive PD-1 inhibitor injections every 3 weeks and 10 subcutaneous injections of personalized tumor neoantigen-based peptide vaccine over a 21-week treatment period.
PD-1 inhibitor injections every 3 weeks and vaccine injections administered according to a specific schedule within the treatment period
Duration - Up to approximately 9 weeks after treatment
After treatment, participants are followed every 6 weeks with venous blood collection, physical examinations, performance status assessments, imaging scans, laboratory tests, and other necessary examinations until the end of the study.
Visits every 6 weeks
Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
2
The First Hospital of Nanchang
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
Y
Yong Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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