A Single-arm, Multicenter, Phase 2 Study of High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

the study conducted to evaluate the efficacy and safety of high-dose furmonertinib (160 mg qd) combined with bevacizumab and pemetrexed intrathecal chemotherapy in NSCLC patients with EGFR mutations and meningeal metastases.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Histological or cytological localization is NSCLC;

• confirmed EGFR exon 19 deletion mutation(19del) or EGFR exon 21L858R mutation (L858R) or EGFR exon 20 T790M mutation (T790M));

• Clinical diagnosis of meningeal aggravation: clinical symptoms of intracranial hypertension (headache, dizziness, vomiting, etc.) + imaging confirmation (cerebral MRI diagnosis of meningeal aggravation) or cerebrospinal fluid cytology confirmation;

• for patients with symptoms who are considered to need temporary brain local. Treatment of cough receiving adrenal corticosteroids must be kept stable or reponse for at least 1 week before the first trial of the drug preparation;

• Newly diagnosed meningeal metastasis, including meningeal metastasis after previous brain surgery and/or local radiotherapy for solid metastatic disease;

• Patients had not received previous systemic treatment for advanced NSCLC or had meningeal metastases after treatment with one third-generation EGFR-TKI.

• Obtain informed consent signed by the patient's legal representative;

• Aged ≥18 years and ≤75 years;

• Eastern Tourism Cooperation Group (ECOG) Physical condition evaluation 0-1;

• Life expectancy ≥12 week;

• Able to follow the requirements of the study protocol and confirmation procedures, and able to accept cranial wall medications;

• contraception.

Locations
Other Locations
China
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Likun Chen
chenlk@sysucc.org.cn
13798019964
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 30
Treatments
Experimental: Furmonertinib combined with bevacizumab and intrathecal pemetrexed chemotherapy
patients receive furmonertinib (160mg, once a day) combined with bevacizumab (7.5 mg/kg, once every 3 weeks) and pemetrexed (50 mg intrathecal injection chemotherapy, once every 3 weeks, up to 9 cycles).
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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