New drug zorifertinib aims to fight lung cancer in the brain

NCT ID NCT07143045

Disease control Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a drug called zorifertinib as the first treatment for people with advanced non-small cell lung cancer that has a specific gene mutation (EGFR) and has spread to the brain or spinal cord. The trial will enroll 800 participants and compare zorifertinib to other similar drugs. The main goal is to see if zorifertinib helps people live longer and controls the cancer better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: zorifertinib
What this could lead to: If successful, zorifertinib could become a new first-line option for people with this type of lung cancer that has spread to the brain, potentially improving survival and controlling the disease longer.
What could go wrong: This is an observational study, not a randomized controlled trial, so results may be less definitive. Side effects are possible, and the drug may not prove better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with advanced non-small cell lung cancer (NSCLC) who have been diagnosed with epidermal growth factor receptor mutation type (EGFRm+) and have central nervous system (CNS) metastasis

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Male or female, aged ≥18 years. 2. Histologically or cytologically confirmed NSCLC with EGFR sensitizing mutations (including L858R or Exon 19Del), ineligible for curative surgery or radiotherapy. 3. CNS metastases diagnosed as brain metastases (BM) and/or leptomeningeal metastases (LM) by imaging and/or cerebrospinal fluid pathological examination. 4. Planning to receive zorifertinib (zorifertinib group) or other anti-tumor treatments (other treatment group) as first-line treatment. 5. Voluntarily agreeing to participate in this study and signing the informed consent form. Exclusion criteria: 1. Currently participating or planning to participate in any interventional clinical study for first-line treatment (patients who have participated in non-interventional, real-world studies may still be included). 2. Other reasons that, in the Investigator's opinion, make the patient unsuitable for this study. For patients in Cohort A of the zorifertinib group, the following inclusion/exclusion criteria of the EVEREST study must also be met: Inclusion Criteria A: 1. . No prior treatment with chemotherapy, EGFR-TKIs, biological therapy, immunotherapy, or any investigational drug that is considered first line treatment for advanced NSCLC. 2. . Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician. 3. . 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. 4. . Patients may have prior placement of a properly functioning CNS shunt or Ommaya reservoir. 5. . ECOG performance status 0 or 1, with no deterioration over the past 2 weeks, and expected survival time ≥ 3 months. 6. . Women of child-bearing potential (WOCBP) and male patients should agree to take medically acceptable contraception measures while on study treatment and for 3 months following completion of study treatment. All WOCBP must have a negative pregnancy test at screening. 7. . Patients with measurable CNS lesions must have at least one site of CNS lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter by MRI, and is suitable for accurate repeated measurements. Measurable extracranial lesions are not required. Patients with non-measurable CNS lesions must have at least one extracranial lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except for lymph nodes which must have a short diameter ≥ 15 mm) by CT/MRI, and is suitable for accurate repeated measurements. Exclusion Criteria A: 1. . Prior treatment with EGFR-TKIs (if EGFR-TKIs were used as adjuvant therapy, patients may be enrolled if the time from discontinuation to relapse meets the following requirements: \>6 months for Cohort A, and \>3 months for Cohorts B and C). 2. . Positive for T790M mutation documented by central or local laboratory using an approved or validated test method, or documented positive KRAS or cMET. 3. . Patients who have received any investigational drug, biological therapy, or immunotherapy for their malignant tumors within the past 21 days. 4. . Patients who have had a major surgical procedure (excluding the need for placement of vascular access or a CNS shunt), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study. 5. . Presence of only leptomeningeal metastases (LM) disease confirmed by MRI and/or positive cerebrospinal fluid (CSF) pathology, with no brain metastases (BM). 6. . Prior radiation therapy for CNS metastases that involves measurable or non-measurable sites of disease to assess efficacy. 7. . Patients who have received radiation to more than 30% of the bone marrow within 2 weeks before the first dose of study treatment. 8. . Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of study treatment) certain medications or herbal supplements that are known to be potent inhibitors or inducers of CYP3A4/5 (see Appendix A). 9. . Unmanageable nausea and vomiting, chronic gastrointestinal diseases, or prior gastric resection or surgical procedure that may interfere with adequate absorption of study drug. 10. . History of concurrent and/or other active malignant tumors requiring treatment within 5 years of study treatment, excluding prior treated squamous cell carcinoma or basal cell carcinoma or carcinoma in situ. 11. . History of any type of documented interstitial lung disease or radiation pneumonitis. 12. . Presence of any severe or uncontrolled systemic disease or condition, including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary or renal disorders; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral, fungal or other infection that would pose a significant risk to the patient in the opinion of the Investigator; or (v) active hepatitis B virus positive (defined as hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and hepatitis B DNA positive (or detectable) or above the cut-off value) or positive HCV antibodies or positive HIV test result. 13. . Women who are pregnant or lactating. WOCBP and fertile men with a WOCBP-partner not using adequate contraception measures. 14. . Patients with unstable and symptomatic metastases: Any unstable and symptomatic CNS or distant metastasis that is not symptomatically controlled by prior surgery, radiotherapy or corticosteroid therapy within 2 weeks of initial study treatment. 15. . Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of starting study treatment, with exception of alopecia. 16. . Patients with a significant cardiovascular disorder or condition, including any of the following: 1. Congestive heart failure (CHF) currently requiring treatment and patients with New York Heart Association (NYHA) Class III/IV CHF (see Appendix B). 2. Need for antiarrhythmic drug therapy for a ventricular arrhythmia or patients with uncontrolled or unstable arrhythmias. 3. Severe conduction disturbance (e.g., second- or third-degree AV block). 4. Angina pectoris requiring treatment. 5. QTc interval \> 450 msec (males) or \> 470 msec (females). 6. History of congenital long QT syndrome, congenital short QT syndrome, Torsades de Pointes, or Wolff Parkinson White syndrome. 7. Left ventricular ejection fraction (LVEF) \<50% as determined by echocardiography or MUGA scan. 8. Myocardial infarction diagnosed within the past 6 months. 17. . Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: 1. Absolute neutrophil count \<1.5 × 109/L. 2. Platelet count \<100 × 109/L (Transfusion-dependent patients are excluded from this study). 3. Hemoglobin \<90 g/L. 4. Alanine aminotransferase (ALT) \> 2.5 times the upper limit of normal (ULN) in the absence of documented metastases to liver or \> 5 times the ULN in the presence of metastases to liver. 5. Aspartate aminotransferase (AST) \> 2.5 times the ULN in the absence of documented metastases to liver or \> 5 times the ULN in the presence of metastases to liver. 6. Total bilirubin \> 1.5 times the ULN in the absence of metastases to liver or \>3 times the ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or metastases to liver. 7. Creatinine \>1.5 times the ULN concurrent with creatinine clearance \<50 mL/min (measured or calculated by Cockcroft-Gault equation). Confirmation of creatinine clearance is only required when creatinine is \>1.5 times the ULN. 8. If bone metastases are present and liver function is otherwise considered adequate by the Investigator, then isolated elevated alkaline phosphatase (ALP) is not an exclusion criterion. 18. . History of hypersensitivity to active or inactive excipients of the study drug or drugs with a similar chemical structure or class to the study drug. 19. . Judgment by the Investigator that the patient should not participate in the study if the patient is unwilling to comply with all study procedures and treatment. 20. . History of recent stroke (\<6 months), or prior central nervous system injury that has persistent neurologic deficits that would affect neurologic assessments. 21. . Significant medical or psychiatric illness that would interfere with the compliance to the protocol and ability to tolerate treatment. 22. . Patients who have received any anti-neoplastic herbal medicines for their malignant tumors within the past 2 weeks.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm in the brain Neoplasm Metastasis neoplastic meningitis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central nervous system (CNS) metastases EGFR mutant advanced non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

34 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Cancer Hospital of Guangxi Medical University
NOT_YET_RECRUITING

Nanning, Guangxi, 530000, China
Beijing Tumor Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100000, China
Capital Medical University Affiliated Beijing Chest Hospital
RECRUITING

Beijing, Beijing Municipality, 100000, China
Chengdu Third People's Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610000, China
Chongqing University Affiliated Cancer Hospital
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 404100, China
Dalian University of Technology Affiliated Central Hospital (Dalian Central Hospital)
NOT_YET_RECRUITING

Dalian, Shandong, 116000, China
First Hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130000, China
Foshan First People's Hospital
RECRUITING

Foshan, Guangdong, 510000, China
Fujian Cancer Hospital
NOT_YET_RECRUITING

Fuzhou, Fujian, 350000, China
Guangdong Provincial People's Hospital
RECRUITING

Guangzhou, Guangdong, 510000, China
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
NOT_YET_RECRUITING

Zhenzhou, Henan, 450000, China
Heyou Hospital, Shunde District, Foshan City
NOT_YET_RECRUITING

Foshan, Guangdong, 528000, China
Hunan Cancer Hospital
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210000, China
Meizhou People's Hospital
RECRUITING

Meizhou, Guangdong, 510000, China
Nanjing Chest Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210000, China
Northern Jiangsu People's Hospital
NOT_YET_RECRUITING

Yangzhou, Jiangsu, 225000, China
People's Liberation Army Army Specialized Medical Center
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 404100, China
Qingdao University Affiliated Hospital
NOT_YET_RECRUITING

Qingdao, Shandong, 266000, China
Shanxi Bethune Hospital
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030000, China
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING

Shenzhen, Shenzhen, 518000, China
Shenzhen Third People's Hospital
NOT_YET_RECRUITING

Shenzhen, Shenzhen, 518000, China
Sichuan Cancer Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610000, China
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING

Hefei, Anhui, 230000, China
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING

Nanning, Guangxi, 530000, China
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING

Nanchang, Jiangxi, 330000, China
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING

Xiamen, Fujian, 350000, China
The First Hospital of China Medical University
NOT_YET_RECRUITING

Shenyang, Liaoning, 110000, China
Tianjin Cancer Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 30000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING

Wuhan, Hubei, 430000, China
Xiangya Hospital, Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 41000, China
Yunnan Cancer Hospital
NOT_YET_RECRUITING

Kunming, Yunnan, 650000, China
Yunnan Provincial First People's Hospital
NOT_YET_RECRUITING

Kunming, Yunnan, 650000, China

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