Actively Recruiting
Cranial Radiotherapy Plus PD-1/PD-L1 Inhibitors and Chemotherapy in Untreated Driver-mutation Negative Non-small Cell Lung Cancer With Active Brain Metastasis (BRILLIANT-1)
Led by Fudan University · Updated on 2024-08-28
40
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and often spreads to the brain, causing brain metastases (BM). Historically, patients with advanced NSCLC and BM had a median survival under six months with chemotherapy. Recent advances with immune checkpoint inhibitors (ICIs), especially when combined with chemotherapy, have shown promise in improving response rates and survival. However, challenges like treatment resistance and recurrence persist, highlighting the need for better treatments. This phase 2 study focuses on combining brain radiotherapy with PD-1/PD-L1 inhibitors and chemotherapy in patients with untreated NSCLC without driver gene mutations who have active brain metastases. Participants with active brain metastases will receive a combination of PD-1/PD-L1 inhibitors and chemotherapy alongside stereotactic radiotherapy (SRT) or whole brain radiation therapy (WBRT), depending on individual brain metastasis conditions. The study aims to assess the safety and effectiveness of this combined approach, which recent data suggest may improve local control and survival while maintaining safety. This treatment plan targets patients who have not received prior therapy and have brain lesions larger than 5mm. During the study, patients will undergo thorough baseline assessments including enhanced brain MRI and systemic lesion evaluation before treatment begins. Researchers will monitor overall survival, response rates, progression-free survival, and treatment-related side effects over one year. The study involves careful safety monitoring and ongoing evaluations to understand how well the combination therapy controls brain metastases and overall disease, with a goal to improve outcomes in this challenging patient group.
CONDITIONS
Brief Title
Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Active 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 common driver genes including EGFR, ALK, ROS-1
- 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 5mm on thin-section brain MRI
- Active brain metastases not controlled by symptom treatment such as mannitol or dexamethasone
- Complete baseline assessment of systemic lesions before treatment including enhanced brain MRI
- Provided informed consent to participate
You will not qualify if you...
- Multiple primary or metastatic tumors except treated early skin cancer or cervical carcinoma in situ with no recurrence for over 5 years
- Severe autoimmune diseases including active inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis
- Unsuitable for brain MRI or stereotactic brain radiotherapy as judged by researcher
- Presence of EGFR, ALK, or ROS1 gene mutations
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders affecting consent or compliance
- Symptomatic interstitial lung disease or active infection/non-infectious pneumonia
- Risk factors for intestinal perforation such as active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal cancer
- Active infection, heart failure, recent myocardial infarction within 6 months, unstable angina, or unstable arrhythmia
- Other uncontrollable diseases or findings that may interfere with results or increase treatment risks
- Tumors mixed with small cell lung cancer components
- Pregnant or lactating women
- Congenital or acquired immunodeficiency including HIV or history of organ/stem cell transplantation
- Known hepatitis B or C virus, active pulmonary tuberculosis infection
- Receipt of tumor vaccines or other vaccines within 4 weeks before treatment start except inactivated seasonal influenza vaccines
- Concurrent use of other immunomodulators, chemotherapy drugs, or participation in other clinical studies
- Long-term corticosteroid treatment
- 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.
1 visit (in-person)
Duration - Up to 1 year
Participants receive cranial radiotherapy combined with PD-1/PD-L1 inhibitors and chemotherapy to treat active brain metastases.
Weekly visits for treatment administration and monitoring
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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