Sun-Yat-Sen university
Guangdong, Guangzhou, 510000, China
Location status: Recruiting
NCT Number: NCT05768490
This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Guangdong, Guangzhou, 510000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment.
almonertinib po 110mg QD
Time frame: 3 years
The time from randomization to death from any cause.
Time frame: 2 years
patients were randomized from the time of observation of intracranial disease progression or death from any cause
Time frame: 2 years
patients were randomized from the time of observation of systemic disease progression or death from any cause
Time frame: 6 months
proportion of patients with complete or partial response of intracranial lesions
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
A Prospective, Multicenter, Randomized, Controlled Clinical Study of Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
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