Actively Recruiting
Personalized Tumor 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
13 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) that has progressed after second-line treatment. This Phase 2 study aims to assess the safety and effectiveness of a personalized tumor neoantigen-based peptide vaccine, PD-1 inhibitor therapy, and radiotherapy in these patients. The study follows ethical guidelines and includes 10 participants who have experienced disease progression despite prior standard treatments. Participants will receive a personalized radiotherapy course followed by PD-1 inhibitor injections every three weeks. Alongside these treatments, they will get 10 subcutaneous injections of a personalized neoantigen-based peptide vaccine over a 21-week period. The vaccine preparation involves detailed genetic and bioinformatics analysis from blood samples to create tailored peptides that target tumor-specific mutations. This combined treatment plan is designed individually for each patient by their doctor. During the study, participants will undergo regular follow-up visits every six weeks, including blood draws, physical exams, performance assessments, imaging scans (CT/MRI, X-rays), and laboratory tests. Researchers will monitor the objective response rate, disease control rate, adverse events, progression-free survival, and overall survival. The study duration includes treatment and follow-up, with outcome assessments extending up to approximately 30 weeks for primary measures and up to 66 months for survival outcomes.
CONDITIONS
Brief 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 who require radiotherapy for metastatic lesions
- At least one measurable lesion
- Aged 18-70, regardless of gender
- Disease progression 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 0-1
- Female patients of childbearing age must have a negative pregnancy test and agree to effective contraception for 6 months
- Able to undergo all required laboratory tests during screening
- Normal major organ function including heart, liver, and kidney
- Specific hematologic and biochemical parameters within defined limits
- No active hepatitis, AIDS, syphilis, or other infections
- Rheumatoid panel and thyroid function tests within normal ranges
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Patients with uncontrollable brain metastases
- Expected to require other antitumor treatments during the study including chemotherapy or surgery
- Use of systemic corticosteroids or other immunosuppressants within 14 days before first dose (except inhalational or topical corticosteroids without active autoimmune diseases)
- Treatment with anticancer immunotherapies or immunostimulatory drugs within 3 months before first dose
- Participation in other clinical trials within 4 weeks before first dose
- Severe cardiovascular diseases or unstable heart conditions within months before first dose
- Poorly controlled hypertension despite medication
- Significant bleeding symptoms or tumors invading major blood vessels
- Recent arterial or venous thrombotic events within 3 months
- Active tuberculosis or serious infections within 4 weeks before first dose
- History of tissue or organ transplantation
- Uncontrolled epilepsy 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
- Any condition deemed unsuitable by the 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 based on individual treatment plans
Participants receive a personalized radiotherapy treatment course before other treatments begin.
Visit schedule determined by the treating physician
Duration - 21 weeks
Participants receive PD-1 inhibitor injections every 3 weeks and 10 subcutaneous injections of personalized neoantigen-based peptide vaccine over 21 weeks.
PD-1 inhibitor injections every 3 weeks; 10 vaccine injections with specific spacing over treatment period
Duration - Until study completion (approximately 9 weeks after treatment)
Participants are followed every 6 weeks with assessments including blood collection, physical exams, scans, and laboratory tests.
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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