Actively Recruiting
Personalized Neoantigen-based Peptide Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment
Led by The First Affiliated Hospital of Nanchang University · Updated on 2024-12-30
10
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment involving a personalized tumor neoantigen-based peptide vaccine, PD-1 inhibitor, and radiotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has progressed after second-line therapy. This Phase 2 study aims to assess the treatment's effectiveness and safety by observing the objective response rate (ORR), disease control rate (DCR), adverse events, progression-free survival, and overall survival. The treatment plan starts with a personalized radiotherapy course determined by the patient's primary physician. After completing radiotherapy, patients receive PD-1 inhibitor injections every three weeks intravenously. Alongside, a personalized peptide vaccine is administered in two phases: a primary phase with six treatments (first three spaced weekly, next three every two weeks) and a boost phase with four treatments spaced three weeks apart. The vaccine injections occur on the fourth day of the treatment week, with the entire treatment period lasting approximately 21 weeks. Participants will be closely monitored throughout the study and followed every six weeks after treatment completion until the study ends. Follow-up visits include venous blood collection, physical exams, performance status assessments, imaging scans (CT/MRI, X-ray), laboratory tests, and other necessary evaluations. Researchers will track treatment responses, disease control, and safety outcomes over an average of 30 weeks to better understand the combined therapy's impact.
CONDITIONS
Official Title
Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-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 between 18 and 70 years, any gender
- Disease progressed after standard second-line therapy with more than 2 weeks since last antitumor treatment
- Expected survival of at least 3 months
- ECOG performance status of 0 or 1
- Female patients of childbearing age must have a negative pregnancy test and agree to effective contraception with no pregnancy plans for 6 months
- Ability to undergo all required screening laboratory tests
- Normal major organ function including heart, liver, and kidney
- Hematologic parameters within specified limits (neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, creatinine, blood urea nitrogen, coagulation times)
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel results within defined ranges
- Thyroid function tests within normal ranges
- Adrenocorticotropic hormone levels within 1.1-17.6 pmol/L
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Uncontrollable brain metastases
- Need for any other antitumor treatment during the study including maintenance therapy, chemotherapy, or surgery
- Systemic corticosteroid or immunosuppressant use above 10 mg/day prednisone equivalent within 14 days before first dose (inhaled/topical corticosteroids allowed if no active autoimmune diseases)
- Anticancer immunotherapy or immunostimulatory drug use within 3 months before first dose
- Participation in other clinical trials with less than 4 weeks since last dose
- Severe cardiovascular diseases (NYHA Class II or higher, recent myocardial infarction, cerebrovascular events within 3 months, unstable arrhythmias or angina)
- Uncontrolled myocardial ischemia or infarction, poorly controlled arrhythmias
- Uncontrolled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- Significant bleeding symptoms or tumors invading major blood vessels with bleeding risk
- Recent arterial or venous thrombotic events within 3 months
- Active tuberculosis or serious infection within 4 weeks before first dose
- Tissue or organ transplant history or preparation
- Uncontrolled epilepsy, CNS 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 by investigator for any reason
AI-Screening
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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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