Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.
Sponsor: The First Affiliated Hospital of Nanchang University
You may qualify if…
- ✓ 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 first-line therapy, and more than 2 weeks since the end of the last antitumor treatment;
- ✓ Expected survival of ≥3 months;
- ✓ ECOG performance status of 0-1;
- ✓ Female patients of childbearing age must have a negative pregnancy test and be able to take effective contraceptive measures with no plans for pregnancy within six months of the study;
- ✓ Able to undergo all screening period laboratory tests as required by the protocol;
You may not qualify if…
- ✕ Disease-specific exclusion criteria:
- ✕ Patients with uncontrollable brain metastases;
- ✕ Subjects expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and/or surgical resection.
- ✕ Subjects who have required systemic treatment with corticosteroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first dose. Inhalational or topical corticosteroids are allowed in the absence of active autoimmune diseases;
- ✕ Subjects who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 3 months before the first dose;
- ✕ Subjects participating in other clinical trials or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical trial (last dose);
- ✕ Subjects with severe cardiovascular diseases, such as those meeting NYHA Class II or higher criteria, myocardial infarction, or cerebrovascular accidents (cerebral ischemia, symptomatic cerebral embolism, etc.) occurring within 3 months before the first dose, or unstable arrhythmias or unstable angina within 1 month before starting study treatment;
- ✕ Subjects with uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias are excluded;
Source: ClinicalTrials.gov · NCT06752044 · last updated 2024-12-30