NCT06702826 Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases
| NCT ID | NCT06702826 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rongrong Zhou |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-11-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. 18 years old ≤ 75 years old; Both male and female; 2. ECOG 0-1; 3. Histologically or cytologically confirmed non-small cell lung cancer; 4. Progression with brain metastasis after previous first-line anti-tumor therapy; 5. 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 volume of brain metastases involved was less than 15 cm3. 6. Response to previous checkpoint inhibitor therapy on the initial response assessment; 7. If a metastatic lesion of the head has been irradiated, the cumulative radiation dose does not exceed the tolerated dose to all structures. 8. For patients with measurable CNS lesions, the longest diameter on MRI images is ≥10mm, which is suitable for repeated and accurate measurement. 9. Subjects 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. 10. Subjects had to have a baseline brain MRI scan within 14 days before the first dose of medication. 11. Estimated survival time \> 12 weeks. 12. 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. 13. Patients who are not lactating. 14. Have definite and good organ functions: 15. 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. Exclusion Criteria: Subjects who meet any of the following criteria are not eligible to participate in the study: 1. Experienced grade 3-4 intracranial toxicity (pituitary or central nervous system toxicity); 2. No measurable intracranial metastatic lesions without radiotherapy; 3. Meningeal metastasis; 4. 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; 5. Have significant autoimmune diseases 6. Prior treatment with a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor. 7. Previous (within 5 years) or concurrent other malignant tumors 8. History of anaphylaxis to any monoclonal antibody and/or study drug component. 9. A history of or current noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoids. 10. Serious infection within 4 weeks before the first dose. 11. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 12. Subjects required systemic treatment with corticosteroids (\>10mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days before taking the study drug. 13. Patients with clinically significant cardiovascular disease 14. Enroll in another clinical study at the same time, unless it is an observational, noninterventional clinical study or a follow-up of an interventional study. 15. Received live vaccine within 30 days before the first dose, or planned to receive live vaccine during the study. 16. Known history of mental illness, substance abuse, alcohol or drug abuse. 17. Pregnant or lactating women. 18. 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 best interest of the subject to participate in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06702826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06702826 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06702826 currently recruiting?
Yes, NCT06702826 is actively recruiting participants. Contact the research team at zhourr@csu.edu.cn for enrollment information.
Where is the NCT06702826 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06702826 clinical trial?
NCT06702826 is sponsored by Rongrong Zhou. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.