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New treatment option for Advanced NSCLC
Official title Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment
ClinicalTrials.gov ID: NCT06751901
What this study is testing
What is PD-1 inhibitor?
PD-1 inhibitor is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 second-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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 21 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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 second-line therapy, and more than 2 weeks since the end of the last antitumor treatment;
- Expected survival of ≥3 months;
You likely can't join if
- Disease-specific exclusion criteria:
- Patients with uncontrollable brain metastases;
- people expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and/or...
- people who have required systemic treatment with corticosteroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days...
- people who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune...
- people 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...
See the full eligibility criteria
- 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, 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;
- Normal major organ function, such as heart, liver, and kidney;
- Hematologic parameters: neutrophil count ≥1.5×10\^9/L, hemoglobin ≥10g/dL, platelet count ≥100×10\^9/L, total bilirubin ≤1.5 times the upper limit of normal, AST and ALT ≤2.5 times the upper limit of normal, creatinine...
- No active hepatitis, AIDS, syphilis, or other infectious diseases;
- Rheumatoid panel: C-reactive protein (CRP) ≤10.0mg/L; Anti-streptolysin O (ASO) \<500U; Erythrocyte sedimentation rate ≤15mm/h (men) or 20mm/h (women);
- Thyroid function tests: 0.27mIU/L ≤ Thyroid-stimulating hormone (TSH) ≤ 4.2mIU/L; 3.1pmol/L ≤ Free triiodothyronine (FT3) ≤ 6.8pmol/L; 12pmol/L ≤ Serum free thyroxine (FT4) ≤ 22pmol/L; 1.3nmol/L ≤ Serum total...
- Adrenocorticotropic hormone (ACTH): 1.1-17.6pmol/L;
- Ability to understand and voluntarily sign a written informed consent form.
- Disease-specific exclusion criteria:
- Patients with uncontrollable brain metastases;
- people expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and/or surgical resection. Exclusion criteria for medical history and...
- people 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...
- people 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;
- people 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);
- people 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...
- people with uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias are excluded;
- people with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg) (Note: a stable antihypertensive regimen should be in...
- people who have had significant clinically relevant bleeding symptoms or a clear bleeding tendency within 3 months before the first dose, as well as tumors that have invaded major blood vessels or, in the investigator's...
- people who have experienced arterial/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism), deep vein thrombosis, and pulmonary...
- people with active tuberculosis;
- people who have had a serious infection within 4 weeks before the first dose, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; people with any active infection;
- people preparing for or who have previously undergone tissue/organ transplantation;
- people with uncontrolled epilepsy, central nervous system disorders, or neurological diseases resulting in cognitive impairment;
- people with a history of splenectomy. Other exclusion criteria:
- Pregnant or breastfeeding women;
- people with a severe history of allergies or atopic constitution;
- people with a history of chronic alcohol or drug abuse within 6 months before enrollment;
- people deemed unsuitable for the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 21 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.