Observing the effects of Furmonertinib on lung cancer patients with brain metastasis

Efficacy and Safety of Furmonertinib for Epidermal Growth Factor Receptor (EGFR) Sensitive Mutation Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis: a Prospective Observational Study

This study is testing if a new drug called Furmonertinib can help lung cancer patients with brain metastases feel better and stay safe while receiving treatment.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Drugs / interventions: Furmonertinib, Fumonertinib, chemotherapy
• Locations: 1 site (Xi'an, Shanxi)
• Trial ID: NCT06352502 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the efficacy and safety of Furmonertinib in patients with EGFR-sensitive mutation positive non-small cell lung cancer (NSCLC) who also have brain metastases. Approximately 30 patients will be recruited in China, and their responses to Furmonertinib treatment will be monitored. The study focuses on patients who have not received prior treatment with other EGFR inhibitors and have confirmed brain metastases. Data on treatment outcomes and safety will be collected to assess the potential benefits of this therapy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed metastatic non-squamous NSCLC and untreated brain metastases.

Not a fit: Patients who have previously received treatment with other EGFR inhibitors or have known hypersensitivity to Furmonertinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with EGFR mutation-positive NSCLC and brain metastases, potentially improving their prognosis.

How similar studies have performed: Other studies have shown promising results with similar approaches, particularly with Furmonertinib's efficacy in treating CNS metastases in EGFR mutation-positive NSCLC.

Eligibility criteria

Inclusion Criteria:

1. at least 18 years of age;
2. Histologically or cytologically confirmed metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC);
3. Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.( EGFR L858R or Del 19 with/without T790M )
4. Imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation;
5. Organ function is compatible with oral Furmonertinib therapy (investigator determination based on real-world practice);
6. Life expectancy ≥12 weeks before Fumonertinib initiation;
7. ECOG PS of 0 to 2;
8. Sign the informed consent form.

Exclusion Criteria:

1. Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation;
2. Known hypersensitivity to Furmonertinib or its excipient components;
3. Simultaneous systemic chemotherapy or WBI;
4. The time from the treatment with any other investigational product or its analogue before Furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
5. Any evidence of severe or uncontrolled systemic diseases;
6. Presence of any disease that may strongly interfere with oral drug absorption; presence of any factor that contributes to QTc prolongation or increased risk of arrhythmia; presence of interstitial pneumonitis.

Where this trial is running

Xi'an, Shanxi

• Tangdu Hopspital — Xi'an, Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Haichuan Su, PhD — Tang-Du Hospital
• Study coordinator: Haichuan Su, PhD

Conditions EGF-R Positive Non-Small Cell Lung Cancer; CNS Metastases; EGFR; NSCLC; Furmonertinib; CNS metastases