Recruiting

Zorifertinib for EGFR-mutant Advanced NSCLC with CNS Metastases

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Neoplasm Metastasis+2

+ Neoplasms

+ Neoplastic Processes

Over 18 Years
+36 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2025
See protocol details

Summary

Principal SponsorAlpha Biopharma (Jiangsu) Co., Ltd.
Study ContactJohn Ge M.D.
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 29, 2025

Actual date on which the first participant was enrolled.

This study investigates the potential benefits of using zorifertinib as the first treatment option for patients with a specific type of advanced lung cancer called non-small cell lung cancer (NSCLC), which has spread to the brain. The study focuses on patients whose cancer shows mutations in the epidermal growth factor receptor (EGFR), a common target in cancer treatment. By comparing zorifertinib to other similar treatments, the study aims to understand if it can improve survival rates and safety for these patients. This is important because finding effective treatments for this type of cancer can significantly improve quality of life and outcomes for patients. Participants in this study receive zorifertinib and are monitored over time to measure how long they live after starting the treatment, regardless of the cause of death. This measurement, called overall survival, helps determine the effectiveness of the treatment. The study takes place across multiple centers and involves different groups of patients to ensure comprehensive results. Safety and potential side effects are also closely observed to ensure the treatment is both effective and safe for patients.

Official TitleA 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
NCT07143045
Principal SponsorAlpha Biopharma (Jiangsu) Co., Ltd.
Study ContactJohn Ge M.D.
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasm MetastasisNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

12 inclusion criteria required to participate
No prior treatment with chemotherapy, EGFR-TKIs, biological therapy, immunotherapy, or any investigational drug that is considered first line treatment for advanced NSCLC.

Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician.

All patients must be stable without any systemic (oral or parenteral) corticosteroid or anticonvulsant therapy for at least 2 weeks prior to study treatment. Inhaled non-absorbable and topical corticosteroid use are permitted as indicated.

Patients may have prior placement of a properly functioning CNS shunt or Ommaya reservoir.

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24 exclusion criteria prevent from participating
Patients who have received radiation to more than 30% of the bone marrow within 2 weeks before the first dose of study treatment.

Significant medical or psychiatric illness that would interfere with the compliance to the protocol and ability to tolerate treatment.

Presence of only leptomeningeal metastases (LM) disease confirmed by MRI and/or positive cerebrospinal fluid (CSF) pathology, with no brain metastases (BM).

Unmanageable nausea and vomiting, chronic gastrointestinal diseases, or prior gastric resection or surgical procedure that may interfere with adequate absorption of study drug.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 34 locations

Recruiting

Capital Medical University Affiliated Beijing Chest Hospital

Beijing, ChinaOpen Capital Medical University Affiliated Beijing Chest Hospital in Google Maps
Recruiting

Foshan First People's Hospital

Foshan, China
Recruiting

Guangdong Provincial People's Hospital

Guangzhou, China
Recruiting

Meizhou People's Hospital

Meizhou, China
Recruiting
34 Study Centers