RecruitingNCT07143045

A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases

Sponsor

Alpha Biopharma (Jiangsu) Co., Ltd.

Enrollment

800 participants

Start Date

Dec 29, 2025

Study Type

OBSERVATIONAL

Conditions

EGFR Mutant Advanced Non-small Cell Lung Cancer Central Nervous System (CNS) Metastases

Summary

This study is a patient-centered, two-group, three-cohort, multi-center, prospective study to further evaluate the survival benefits and safety of zorifertinib as a first-line treatment in EGFRm+ advanced NSCLC patients with CNS metastases, and to compare the clinical value of zorifertinib with other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients with a type of lung cancer (non-small cell lung cancer, or NSCLC) that has spread to the brain and has a specific genetic mutation (EGFR) who are receiving a targeted drug called zorifertinib or other treatments. Researchers want to track how well these treatments work in the real world. **You may be eligible if...** - You are 18 or older with EGFR-mutated non-small cell lung cancer - Your cancer has spread to the brain (brain metastases or cancer in the fluid around the brain) - You are planning to start zorifertinib or another first-line anti-cancer treatment - You are willing to participate and sign informed consent **You may NOT be eligible if...** - You are already enrolled in another interventional clinical trial for your first-line treatment - You have only cancer in the fluid surrounding the brain (leptomeningeal disease) with no brain tumor visible on MRI - You have received prior EGFR-targeted therapy (for certain sub-groups) - You have significant uncontrolled heart conditions, severe infections, or active liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzorifertinib

Cohort A and B will receive zorifertinib as first line treatment

Locations(34)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Tumor Hospital

Beijing, Beijing Municipality, China

Capital Medical University Affiliated Beijing Chest Hospital

Beijing, Beijing Municipality, China

Chongqing University Affiliated Cancer Hospital

Chongqing, Chongqing Municipality, China

People's Liberation Army Army Specialized Medical Center

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Foshan First People's Hospital

Foshan, Guangdong, China

Heyou Hospital, Shunde District, Foshan City

Foshan, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhenzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Nanjing Chest Hospital

Nanjing, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

First Hospital of Jilin University

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Dalian University of Technology Affiliated Central Hospital (Dalian Central Hospital)

Dalian, Shandong, China

Qingdao University Affiliated Hospital

Qingdao, Shandong, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences

Shenzhen, Shenzhen, China

Shenzhen Third People's Hospital

Shenzhen, Shenzhen, China

Chengdu Third People's Hospital

Chengdu, Sichuan, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Yunnan Provincial First People's Hospital

Kunming, Yunnan, China

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