High-dose furmonertinib combined with bevacizumab and pemetrexed for treating lung cancer with brain metastasis

A Single-center, Real-world Study Aimed At Evaluating the Efficacy and Safety of 240 Mg/d Furmonertinib Combined with Bevacizumab and Pemetrexed in the Treatment of Advanced NSCLC with EGFRm and Leptomeningeal Metastasis.

This study is testing a new combination of three drugs to see if it can help people with non-small cell lung cancer that has spread to the brain live longer and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: radiation, bevacizumab, furmonertinib, chemotherapy, erlotinib, afatinib, gefitinib, osimertinib, alflutinib
• Locations: 2 sites (Zhengzhou, Henan and 1 other locations)
• Trial ID: NCT06643000 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of a triple therapy regimen consisting of high-dose furmonertinib, bevacizumab, and pemetrexed in patients with non-small cell lung cancer (NSCLC) who have leptomeningeal metastasis and an epidermal growth factor receptor mutation (EGFRm). The primary goal is to assess overall survival, while secondary objectives include measuring treatment failure time, response rates, and quality of life impacts. The study also focuses on the safety profile of this combination therapy, monitoring adverse events and their severity. Given the challenges posed by the blood-brain barrier, this approach aims to improve treatment outcomes for a particularly difficult-to-treat patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed NSCLC and positive EGFR mutations who have leptomeningeal metastasis.

Not a fit: Patients with non-EGFR mutations or those with life-threatening CNS symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly extend survival and improve quality of life for patients with advanced lung cancer and leptomeningeal metastasis.

How similar studies have performed: While previous studies on EGFR-TKIs for leptomeningeal metastasis have shown limited efficacy, this novel combination therapy approach may offer new hope for improved outcomes.

Eligibility criteria

Inclusion Criteria:

1. Have obtained written informed consent from the patient or his or her legal representative;
2. The patient is ≥18 years old, male or female;
3. Non-small cell lung cancer confirmed by histological or cytological pathology;
4. Genetic testing confirming positive for classical or non-classical EGFR mutations;
5. After comprehensive clinical evaluation according to the "EANO-ESMO" meningeal metastasis diagnostic criteria, the comprehensive clinical evaluation of patients with definite meningeal metastasis included symptom evaluation, imaging evaluation, and/or cerebrospinal fluid pathology evaluation;
6. Patients with newly diagnosed leptomeningeal metastases and those with disease progression after previous antineoplastic therapy were eligible;
7. ECOG Performance Status 0-3;
8. Prior treatment with radiation or surgery targeting the central nervous system is permitted;
9. Admit patients with CNS symptoms or signs, but those symptoms or signs are not life threatening;
10. Fertile men or women with the possibility of becoming pregnant must use a highly effective method of contraception (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) during the course of the trial and continue contraception for 12 months after the end of treatment.

Exclusion Criteria:

* 1)Patients currently have tumors other than NSCLC; 2)Have had or have a history of other malignancies within the last 5 years, other than basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast that have been effectively controlled; 3)Serious digestive tract diseases that affect drug use and absorption, including but not limited to peptic ulcer, inflammatory bowel disease, etc.

  4)Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, and active bleeding, any that the investigator deems to be detrimental to the patient's participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV); 5)A history of interstitial lung disease, drug-induced interstitial lung disease, prior history of radiation pneumonia requiring steroid treatment, or any evidence of active interstitial lung disease; 6)The presence of significant arrhythmias (such as prolonged QT interval \> 500ms) or heart failure (left ventricular ejection fraction \< 50%) 7)Pregnant or lactating women; 8)Patients who received a live vaccine within 4 weeks before treatment began; 9)Patients who are or have been involved in another clinical study within 4 weeks; 10)Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's opinion, may increase the risks associated with participating in the study or may interfere with the interpretation of the study results; Or subjects who may not be able to complete the study or comply with the requirements of the study (for administrative or other reasons).

Where this trial is running

Zhengzhou, Henan and 1 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Qiming Wang, MD — Henan Cancer Hospital
• Study coordinator: Qi Zhao, MS

Conditions Non-small Cell Lung Cancer; Leptomeningeal Metastasis; EGFR Gene Mutation