Almonertinib Combined With Cerebral Radiation Treat Brain Metastases From EGFR Positive NSCLC
Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
According to literature reports, about 16.3%-19% of newly diagnosed NSCLC patients are
associated with brain metastasis, and 30%-50% of NSCLC patients will develop brain metastasis
during the whole course of the disease.
Patients with EGFR positive-type had a 10-15% higher risk of brain metastasis than patients
with EGFR wild-type. mOS in patients with EGFR positive were twice as high as those with EGFR
wild-type, despite the presence of brain metastasis.
Improving the control rate of intracranial lesions in patients with EGFR positive can not
only improve the quality of life, but also may translate into survival benefits and improve
OS. Previous studies have shown that in lung cancer patients with EGFR-sensitive mutations,
craniocerebral radiotherapy prior to delayed craniocerebral radiotherapy significantly
prolonged OS.
The first-line treatment of the third generation of EGFR-TKI targeting drug Almonertinib for
EGFR-positive NSCLC can eliminate the possible EGFR T790M mutant clones at an early stage and
better control the disease progression. Moreover, Almonertinib is easy to pass through the
blood-brain barrier, which can not only better control intracranial lesions, but also
control, prevent or delay the occurrence of brain metastasis.
This study was intended to conduct a randomized controlled study on the safety and efficacy
of early craniocerebral radiotherapy combined with Almonertinib in patients with EGFR
positive non-small cell lung cancer with brain metastasis.
Through the above studies we hope to confirm that early craniocerebral radiotherapy combined
with Almonertinib is safe and feasible for patients with EGFR positive newly diagnosed with
brain metastasis, and can prolong the intracranial progression-free survival (IPFS), and even
extend the progression-free survival (PFS) and overall survival (OS).