Actively Recruiting
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
Led by Alpha Biopharma (Jiangsu) Co., Ltd. · Updated on 2026-02-09
800
Participants Needed
34
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating zorifertinib as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) that has mutations in the EGFR gene and has spread to the central nervous system (CNS). This prospective study involves multiple centers and compares the survival benefits and safety of zorifertinib to other similar drugs called EGFR tyrosine kinase inhibitors (EGFR-TKIs). The study aims to better understand how well zorifertinib works and its clinical value in this patient group. Participants are divided into three groups: those receiving first-line zorifertinib who meet criteria of the EVEREST study, those receiving zorifertinib but not meeting EVEREST criteria, and those receiving other anti-tumor drugs chosen by their doctors excluding zorifertinib. The EVEREST study is an open-label trial comparing zorifertinib to gefitinib or erlotinib. Treatments are given as prescribed by clinicians, with monitoring of safety and dosage adjustments as needed. During the study, participants will be followed for up to 36 months, with assessments every 8 weeks to measure overall survival, progression-free survival, intracranial progression, response rates, and adverse events. Researchers will track dose changes and monitor safety outcomes over time. The study collects clinical data to evaluate the effectiveness and tolerability of the treatments in patients with EGFR-mutant advanced NSCLC and CNS metastases.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Confirmed non-small cell lung cancer with EGFR sensitizing mutations (L858R or Exon 19Del)
- Diagnosed brain metastases and/or leptomeningeal metastases by imaging or cerebrospinal fluid examination
- Planning to receive zorifertinib or other anti-tumor treatments as first-line therapy
- Voluntarily agree to participate and sign informed consent
- For Cohort A: no prior chemotherapy, EGFR-TKI, biological therapy, immunotherapy, or investigational first-line treatment
- For Cohort A: stable without systemic corticosteroid or anticonvulsant therapy for at least 2 weeks prior
- For Cohort A: ECOG performance status 0 or 1, no recent deterioration, expected survival of 3 months or more
- For Cohort A: women of child-bearing potential and men agree to contraception during and 3 months after treatment
- For Cohort A: measurable CNS lesions suitable for accurate measurement by MRI or CT
You will not qualify if you...
- Currently participating or planning participation in any interventional first-line treatment study
- Investigator’s judgment of unsuitability for the study
- For Cohort A: prior treatment with EGFR-TKIs within specific timeframes
- Positive for T790M mutation or documented positive KRAS or cMET mutations
- Received investigational drugs, biological therapy, or immunotherapy within past 21 days
- Recent major surgery or traumatic injury within 4 weeks before treatment
- Only leptomeningeal metastases without brain metastases
- Prior radiation therapy involving CNS measurable or non-measurable disease sites
- Radiation to more than 30% of bone marrow within 2 weeks before treatment
- Use of medications or supplements affecting CYP3A4/5 that cannot be stopped
- Gastrointestinal conditions affecting drug absorption
- Recent or active other malignancies requiring treatment
- History of interstitial lung disease or radiation pneumonitis
- Severe or uncontrolled systemic diseases or infections
- Pregnant or lactating women; inadequate contraception
- Unstable or symptomatic metastases not controlled by prior therapy
- Unresolved toxicities greater than CTCAE Grade 1 except alopecia
- Significant cardiovascular disorders including heart failure, arrhythmias, conduction disturbances, angina, prolonged QTc, or recent myocardial infarction
- Inadequate bone marrow or organ function based on lab values
- Hypersensitivity to study drug or similar drugs
- Unwillingness to comply with study procedures
- Recent stroke or CNS injury affecting assessments
- Significant medical or psychiatric illness interfering with study
- Recent use of anti-neoplastic herbal medicines within 2 weeks before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive zorifertinib or other anti-tumor drugs as first-line treatment for their advanced non-small cell lung cancer with CNS metastases.
Visits every 8 weeks for assessments during treatment
Duration - Up to 36 months
Participants are monitored for overall survival and adverse events after treatment.
Visits every 8 weeks for assessments
Trial Site Locations
Total: 34 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Beijing Tumor Hospital
Beijing, Beijing Municipality, China, 100000
Not Yet Recruiting
3
Capital Medical University Affiliated Beijing Chest Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
4
Chongqing University Affiliated Cancer Hospital
Chongqing, Chongqing Municipality, China, 404100
Not Yet Recruiting
5
People's Liberation Army Army Specialized Medical Center
Chongqing, Chongqing Municipality, China, 404100
Not Yet Recruiting
6
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
7
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 350000
Not Yet Recruiting
8
Foshan First People's Hospital
Foshan, Guangdong, China, 510000
Actively Recruiting
9
Heyou Hospital, Shunde District, Foshan City
Foshan, Guangdong, China, 528000
Not Yet Recruiting
10
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
11
Meizhou People's Hospital
Meizhou, Guangdong, China, 510000
Actively Recruiting
12
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
Not Yet Recruiting
13
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
Not Yet Recruiting
14
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
15
Henan Cancer Hospital
Zhenzhou, Henan, China, 450000
Not Yet Recruiting
16
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
17
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
18
Xiangya Hospital, Central South University
Changsha, Hunan, China, 41000
Not Yet Recruiting
19
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
20
Nanjing Chest Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
21
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225000
Not Yet Recruiting
22
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
23
First Hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
24
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
25
Dalian University of Technology Affiliated Central Hospital (Dalian Central Hospital)
Dalian, Shandong, China, 116000
Not Yet Recruiting
26
Qingdao University Affiliated Hospital
Qingdao, Shandong, China, 266000
Not Yet Recruiting
27
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
28
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Shenzhen, Shenzhen, China, 518000
Not Yet Recruiting
29
Shenzhen Third People's Hospital
Shenzhen, Shenzhen, China, 518000
Not Yet Recruiting
30
Chengdu Third People's Hospital
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
31
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
32
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 30000
Not Yet Recruiting
33
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650000
Not Yet Recruiting
34
Yunnan Provincial First People's Hospital
Kunming, Yunnan, China, 650000
Not Yet Recruiting
Research Team
J
John Ge M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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