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
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
- Histologically or cytologically confirmed NSCLC with EGFR sensitizing mutations (L858R or Exon 19Del) not eligible for curative surgery or radiotherapy
- CNS metastases diagnosed by imaging or cerebrospinal fluid examination
- Planning to receive zorifertinib or other anti-tumor treatments as first-line therapy
- Voluntarily agreeing to participate and signing informed consent
- For Cohort A: no prior chemotherapy, EGFR-TKIs, biological therapy, immunotherapy, or investigational drugs for advanced NSCLC
- For Cohort A: ineligible for definitive surgical resection or radiation of all lesions
- For Cohort A: stable without systemic corticosteroid or anticonvulsant therapy for at least 2 weeks prior to treatment
- For Cohort A: may have CNS shunt or Ommaya reservoir placement
- For Cohort A: ECOG performance status 0 or 1 with no recent deterioration and expected survival of 3 months or more
- For Cohort A: WOCBP and male patients agree to contraception during and 3 months after treatment; WOCBP must have negative pregnancy test
- For Cohort A: measurable CNS lesions suitable for accurate repeated measurements or extracranial lesions as specified
You will not qualify if you...
- Currently participating or planning to participate in any interventional clinical study for first-line treatment
- Other reasons making patient unsuitable as judged by Investigator
- For Cohort A: prior treatment with EGFR-TKIs unless specific relapse timing met
- Positive for T790M mutation or documented positive KRAS or cMET
- Received investigational drugs, biological therapy, or immunotherapy within past 21 days
- Recent major surgery or significant trauma within 4 weeks prior to treatment
- Presence of only leptomeningeal metastases without brain metastases
- Prior radiation therapy to CNS metastases involving measurable or non-measurable disease sites
- Radiation to more than 30% of bone marrow within 2 weeks before treatment
- Use of medications or supplements that strongly affect CYP3A4/5 enzymes
- Conditions interfering with drug absorption like severe gastrointestinal diseases or prior gastric surgery
- History of other active malignant tumors requiring treatment within 5 years except certain skin cancers
- History of interstitial lung disease or radiation pneumonitis
- Severe or uncontrolled systemic diseases including hypertension, diabetes, cardiac, pulmonary, or renal disorders
- Active infections posing significant risk or positive hepatitis B, C, or HIV tests
- Pregnant or lactating women, or those not using adequate contraception
- Unstable and symptomatic metastases not controlled by prior treatments
- Unresolved toxicities from prior therapy greater than Grade 1 except alopecia
- Significant cardiovascular disorders including severe heart failure, arrhythmias, conduction disturbances, angina, abnormal QTc intervals, recent myocardial infarction
- Inadequate bone marrow reserve or organ function as per specified lab values
- Hypersensitivity to study drug or related compounds
- Inability or unwillingness to comply with study procedures
- Recent stroke or CNS injury affecting assessments
- Significant medical or psychiatric illness interfering with protocol compliance
- Use of anti-neoplastic herbal medicines within past 2 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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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