Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRongrong Zhou
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Cadonilimab combined with SRS
DrugEligible subjects were treated with stereotactic radiotherapy for brain metastases plus Cadonilimab followed by maintenance therapy with Cadonilimab alone
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cadonilimab combined with SRSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
iORR
Intracranial objective response rate (iORR) was defined as the proportion of patients who achieved a prespecified reduction in tumor volume and maintained the minimum time requirement, including CR and PR cases.
Time frame
From date of enrollment until the date of first documented intracranial progression, assessed up to 2 years.Secondary outcomes
1
PFS
Progression-free survival (PFS) : defined as the time from first use of a study drug to documentation of disease progression (according to RECIST v1.1) or death from any cause, whichever occurred first.
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.2
iPFS
Intracranial Progress Free Survival rate (iPFS) : the time from clinical detection of brain metastases to the first occurrence of intracranial progression or death. iPFS was assessed according to the Response Assessment of Brain Metastases in Neurooncology (RANO-BM) criteria.
Time frame
From date of enrollment until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 2 years3
OS
Overall survival (OS) : defined as time from treatment initiation to death from any cause.
Time frame
From date of enrollment until the date of death from any cause, whichever came first, assessed up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rongrong Zhou
Lead sponsor
Xiangya Hospital of Central South University
Sponsor institution
Source ClinicalTrials.gov