Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Jun 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new treatment, combining two medications called furmonertinib and anlotinib, works for patients with lung adenocarcinoma (a type of lung cancer) that has spread to the brain and has specific genetic changes known as EGFR mutations. The main goals of the study are to see if this combination can help shrink tumors and to understand any side effects that might occur.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of lung adenocarcinoma with measurable brain lesions. They should not have received any prior systemic treatment for their cancer and must have a good overall health status. Participants will take furmonertinib daily and anlotinib for two weeks at a time, followed by a break, with regular check-ups every three weeks to monitor their health and record any symptoms they experience. It’s important for potential participants to discuss their medical history with their doctors to see if they meet the eligibility criteria.

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Eligibility criteria

• Inclusion Criteria:
• • Male or Female aged ≥18 years old;
• • Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ;
• • According to RANO-BM, the subject has at least 1 intracranial measurable lesion;
• • Tumor tissue samples or blood samples are confirmed to be EGFR mutations;
• • ECOG PS 0-1;
• • Life expectancy \>12 weeks;
• • No prior systemic antitumor therapy for metastatic NSCLC
• Exclusion Criteria:
• • Patients without lung adenocarcinoma, including lung squamous cell carcinoma or mixed histological type, etc;
• • Expected to receive other anti-tumor therapy other than the investigational product during the study;
• • Having previously received systematic anti-tumor therapy
• • Having received the following therapies: (1) Having been irradiated for \> 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
• • Having a history of other malignant tumor, or other concurrent malignant tumors;
• • The toxicity caused by previous anti-tumor therapy has not recovered to \<= CTCAE grade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-related neurotoxicity) ;
• • Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease;
• • Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product;
• • Recently active digestive disease
• • The patient is prone to bleeding or has active bleeding; Any bleeding event ≥CTCAE grade 3 within 28 days prior to the first study drug;
• • Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, QTc \> 470 ms on ECG at resting state, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval;
• • Bone marrow reserve, liver, kidney organs and other functions are insufficient;
• • There has been an active venous thrombosis event within the last 6 months;
• • Known Active hepatitis B virus , hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection;
• • Infectious disease requiring intravenous medication;
• • Known history of mental disease or drug abuse, and currently having an attack or still taking drugs;
• • Known or suspected allergy to Furmonertinib or other components of its preparation;
• • Female subjects or female partners of male subjects who are pregnant or lactating, or plan to be pregnant during the study;
• • Poor compliance, inability to comply with the study procedures, restriction or requirements;
• • Other conditions that are considered by investigators as unsuitable to participate in this study.