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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 volume of brain metastases involved was less than 15 cm3.

• 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.

• 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.

⁃ Subjects 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.

Locations
Other Locations
China
Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Rongrong Zhou, MD, PHD
zhourr@csu.edu.cn
+8613875898127
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 20
Treatments
Experimental: Cadonilimab combined with SRS
Eligible subjects were treated with stereotactic radiotherapy for brain metastases plus Cadonilimab followed by maintenance therapy with Cadonilimab alone
Sponsors
Leads: Rongrong Zhou

This content was sourced from clinicaltrials.gov