About this trial
Patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with brain metastases remain a major clinical challenge. Although EGFR-TKIs have demonstrated intracranial activity, disease control is still suboptimal in some patients.
Limertinib (ASK120067) is a novel third-generation EGFR tyrosine kinase inhibitor with favorable central nervous system penetration and encouraging intracranial antitumor activity. The potential synergistic effect of limertinib combined with radiotherapy warrants further investigation.
This prospective, multicenter, single-arm phase II study aims to evaluate the efficacy and safety of first-line limertinib combined with radiotherapy in this patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Limertinib Plus Radiotherapy
DrugLimertinib Plus Radiotherapy
Treatment groups
Trial outcomes
Primary outcomes
Intracranial progression-free survival (iPFS)
Intracranial progression-free survival (iPFS) is defined as the time from the initiation of study treatment to the first documented intracranial disease progression or death from any cause, whichever occurs first, as assessed by magnetic resonance imaging (MRI) according to RECIST version 1.1 criteria.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: