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New treatment option for Non Small Cell Lung Cancer
Official title Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases
ClinicalTrials.gov ID: NCT06702826
What this study is testing
What is Cadonilimab combined with SRS?
Cadonilimab combined with SRS is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
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
- 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?
- Phase 2: a mid-size study of how well it works
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 75
You may be able to join if
- 18 years old ≤ 75 years old; Both male and female;
- ECOG 0-1;
- Histologically or cytologically confirmed non-small cell lung cancer;
- Progression with brain metastasis after previous first-line anti-tumor therapy;
- Requirements for brain metastases: ① measurable brain metastases without radiotherapy; ②SRS/FSRT: the maximum tumor volume of brain metastases was...
You likely can't join if
- people who meet any of the following criteria are not eligible to participate in the study:
- Experienced grade 3-4 intracranial toxicity (pituitary or central nervous system toxicity);
- No measurable intracranial metastatic lesions without radiotherapy;
- Meningeal metastasis;
- If receiving chemotherapy or targeted therapy, the washout period should not exceed 3 weeks; if receiving brain metastasis resection, the washout...
- Have significant autoimmune diseases
See the full eligibility criteria
- 18 years old ≤ 75 years old; Both male and female;
- ECOG 0-1;
- Histologically or cytologically confirmed non-small cell lung cancer;
- Progression with brain metastasis after previous first-line anti-tumor therapy;
- Requirements for brain metastases: ① measurable brain metastases without radiotherapy; ②SRS/FSRT: the maximum tumor volume of brain metastases was less than 10cm3, the single diameter was less than 3cm, and the total...
- Response to previous checkpoint inhibitor therapy on the initial response assessment;
- If a metastatic lesion of the head has been irradiated, the cumulative radiation dose does not exceed the tolerated dose to all structures.
- For patients with measurable CNS lesions, the longest diameter on MRI images is ≥10mm, which is suitable for repeated and accurate measurement.
- people were evaluated for all extracranial disease sites (e.g., by computed tomography (CT) scan and bone scan or positron emission tomography (PET-CT) within 14 days before the first dose.
- people had to have a baseline brain MRI scan within 14 days before the first dose of medication.
- Estimated survival time \> 12 weeks.
- Participants of childbearing age must agree to use effective contraception during the trial; In women of childbearing age, a serum or urine pregnancy test must be negative.
- Patients who are not lactating.
- Have definite and good organ functions:
- Provide informed consent voluntarily, and be willing and able to comply with the follow-up, treatment, laboratory testing, and other study requirements specified in the study schedule.
- people who meet any of the following criteria are not eligible to participate in the study:
- Experienced grade 3-4 intracranial toxicity (pituitary or central nervous system toxicity);
- No measurable intracranial metastatic lesions without radiotherapy;
- Meningeal metastasis;
- If receiving chemotherapy or targeted therapy, the washout period should not exceed 3 weeks; if receiving brain metastasis resection, the washout period should not exceed 2 weeks;
- Have significant autoimmune diseases
- Prior treatment with a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor.
- Previous (within 5 years) or concurrent other malignant tumors
- History of anaphylaxis to any monoclonal antibody and/or study drug component.
- A history of or current noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoids.
- Serious infection within 4 weeks before the first dose.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- people required systemic treatment with corticosteroids (\>10mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days before taking the study drug.
- Patients with clinically significant cardiovascular disease
- Enroll in another clinical study at the same time, unless it is an observational, noninterventional clinical study or a follow-up of an treatment study.
- Received live vaccine within 30 days before the first dose, or planned to receive live vaccine during the study.
- Known history of mental illness, substance abuse, alcohol or drug abuse.
- Pregnant or lactating women.
- The presence of any past or current medical conditions, treatments, or laboratory abnormalities may confound the results of the study, interfere with the full participation of the subject in the study, or may not be in...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, 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.