Combining Cadonilimab with Stereotactic Radiotherapy for Brain Metastases Treatment

Efficacy and Safety of Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases From Non-small Cell Lung Cancer (NSCLC) : a Single-arm, Open-label, Phase II Clinical Trial

This study is testing if combining a new drug called Cadonilimab with targeted radiation therapy can help people with brain metastases from lung cancer feel better and have fewer side effects than current treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone, Cadonilimab, immunotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06702826 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Cadonilimab when used alongside stereotactic radiation therapy as a second-line treatment for brain metastases resulting from non-small cell lung cancer (NSCLC). The study aims to determine if this combination yields better outcomes compared to existing treatments and whether the associated toxicity is manageable. Participants will receive the treatment and undergo regular check-ups every 12 weeks to monitor their progress. The trial focuses on patients with specific criteria related to their cancer progression and treatment history.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed NSCLC who have experienced progression with brain metastases after first-line therapy.

Not a fit: Patients with extensive brain metastases or those who have already received high doses of radiation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with brain metastases from NSCLC.

How similar studies have performed: Previous studies have shown that immunotherapy can prolong survival in patients with brain metastases, suggesting potential success for this combined approach.

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.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Rongrong Zhou, MD, PHD

Conditions Non Small Cell Lung Cancer; Brain Metastases; Stereotactic Radiation; Immunotherapy; non small cell lung cancer; brain metastases; SRS; immunotherapy