Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases

ConditionNSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Guangzhou Medical University

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Limertinib Plus Radiotherapy

    Drug

    Limertinib Plus Radiotherapy

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Limertinib Plus RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: