Actively Recruiting
Cranial Radiotherapy Plus PD-1/PD-L1 Inhibitors and Chemotherapy in Patients With Driver-mutation Negative Non-small Cell Lung Cancer With Stable Brain Metastasis (BRILLIANT)
Led by Fudan University · Updated on 2024-08-28
54
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-small cell lung cancer (NSCLC) is the most common lung cancer type and often spreads to the brain, leading to brain metastases (BM). Historically, survival for advanced NSCLC patients with BM was less than six months using traditional chemotherapy. Recent advances with immune checkpoint inhibitors (ICIs), combined with chemotherapy, have shown promising improvements in brain lesion response, progression-free survival, and overall survival. Despite progress, challenges like treatment resistance and recurrence remain. Combining immunotherapy with brain radiotherapy, especially stereotactic radiotherapy (SRT), is emerging as a promising approach for patients with limited brain metastases. This phase 2 clinical trial studies the combination of cranial radiotherapy with PD-1/PD-L1 inhibitors and chemotherapy in patients with driver gene mutation-negative NSCLC who have stable brain metastases. Patients will be randomly assigned to receive either PD-1/PD-L1 inhibitors plus chemotherapy alone or combined with brain radiotherapy using SRT or whole brain radiation therapy (WBRT) based on their brain metastasis condition. The study aims to evaluate the safety and effectiveness of adding radiotherapy to chemoimmunotherapy. Participants will undergo regular brain MRI scans and systemic assessments before and during treatment. Researchers will monitor objective response rates, intracranial progression-free survival, overall survival, and treatment-related side effects over two years. The study includes careful monitoring for adverse events and will follow patients to assess both brain and overall cancer control. The trial is sponsored by Fudan University and plans to enroll adults aged 18 and older with advanced NSCLC and brain metastases without driver mutations.
CONDITIONS
Brief Title
Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Stable Brain Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky Performance Status (KPS) score of 70 or higher
- Negative genetic testing for EGFR, ALK, and ROS-1 driver gene mutations
- Pathologically confirmed non-small cell lung cancer
- Clinical stage IV according to AJCC, 8th edition, 2017
- Diagnosed with brain metastasis at diagnosis, with at least one brain lesion larger than 5 mm on brain MRI
- Complete baseline assessment of systemic lesions including enhanced brain MRI
- Informed consent provided by the patient
You will not qualify if you...
- Multiple primary or metastatic tumors except treated early skin cancer or cervical carcinoma in situ without recurrence for over 5 years
- Severe autoimmune diseases such as active inflammatory bowel disease, rheumatoid arthritis, scleroderma, lupus, or autoimmune vasculitis
- Unsuitability for brain MRI or stereotactic brain radiotherapy as judged by the researcher
- Presence of EGFR, ALK, or ROS1 gene mutations
- Active brain metastases uncontrolled by symptomatic treatment
- Uncontrolled epilepsy, central nervous system disease, or mental disorders interfering with consent or compliance
- Symptomatic interstitial lung disease or active infection or pneumonia
- Risk factors for intestinal perforation including active diverticulitis or gastrointestinal obstruction
- Active infection, heart failure, recent myocardial infarction within 6 months, unstable angina, or arrhythmia
- Other uncontrolled diseases or clinical findings that may interfere with treatment or increase risk
- Presence of small cell lung cancer components
- Pregnant or breastfeeding women
- Immunodeficiency diseases including HIV or history of organ or stem cell transplant
- Known hepatitis B or C, or active pulmonary tuberculosis
- Recent tumor or other vaccinations within 4 weeks before treatment
- Concurrent use of other immunomodulators, chemotherapy drugs, or long-term corticosteroids
- Allergy or contraindication to PD-1/PD-L1 inhibitors or chemotherapy drugs
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.
Duration - Up to 2 years
Participants receive PD-1/PD-L1 inhibitors and chemotherapy with or without cranial radiotherapy to treat non-small cell lung cancer with stable brain metastasis.
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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