Actively Recruiting
Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases
Led by Rongrong Zhou · Updated on 2024-11-25
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of Cadonilimab combined with stereotactic radiation therapy in the second-line treatment of brain metastases from non-small cell lung cancer (NSCLC). The main questions it aims to answer are: * Does Cadonilimab combined with SRT in the second-line treatment of brain metastases provide better results? * Is the toxicity of Cadonilimab combined with SRT manageable in second-line treatment of brain metastases? Researchers will compare evaluate the efficacy and safety of Cadonilimab combined with SRT as a second-line treatment for patients with advanced NSCLC： * Receive Cadonilimab combined with SRT for brain lesions. * Visit the hospital regularly once every 12 weeks for checkups and tests
CONDITIONS
Official Title
Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed non-small cell lung cancer
- Progression with brain metastases after prior first-line anti-tumor treatment
- Measurable brain metastases without prior radiotherapy, with tumor volumes and sizes within specified limits
- Initial positive response to prior checkpoint inhibitor therapy
- If prior brain radiation, cumulative dose within tolerated limits
- Measurable CNS lesions suitable for MRI measurement
- Recent imaging evaluation of extracranial disease sites within 14 days before first dose
- Baseline brain MRI scan within 14 days before first dose
- Estimated survival time greater than 12 weeks
- Use of effective contraception for participants of childbearing potential and negative pregnancy test
- Not lactating
- Adequate organ function
- Willingness to provide informed consent and comply with study requirements
You will not qualify if you...
- History of severe (grade 3-4) intracranial toxicity
- No measurable intracranial metastatic lesions without radiotherapy
- Presence of meningeal metastasis
- Recent chemotherapy or targeted therapy with insufficient washout period
- Significant autoimmune diseases
- Prior treatment with CTLA-4 inhibitors
- Other malignant tumors within past 5 years or concurrent malignancies
- History of anaphylaxis to monoclonal antibodies or study drug components
- History or current noninfectious pneumonia or interstitial lung disease requiring steroids
- Serious infection within 4 weeks before first dose
- History of allogeneic organ or hematopoietic stem cell transplantation
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days before study drug
- Clinically significant cardiovascular disease
- Concurrent enrollment in another interventional clinical study
- Recent or planned live vaccine administration
- History of mental illness, substance abuse, or alcohol/drug abuse
- Pregnant or lactating women
- Any medical condition or abnormality that may interfere with study participation or results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xiangya Hospital, Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
R
Rongrong Zhou, MD, PHD
CONTACT
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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