Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
The period from the first administration date of the study treatment to the date of death due to any cause.
up to 36 months

Secondary Outcomes (5)

Incidence of Adverse Events (AEs) for zorifertinib
up to 36 months
Incidence of Dose Adjustments for zorifertinib
up to 36 months
Progression-free survival (PFS)
every 8 weeks,up to 36 months
intracranial Progression-free survival (iPFS)
every 8 weeks,up to 36 months
Objective Response Rate (ORR)
every 8 weeks, up to 36 months

Other Outcomes (2)

The progression-free survival period of the zorifertinib treatment group (PFS2)
every 8 weeks, up to 36 months
The Genetic Resistance Status
up to 36 months

Study Arms (3)

Cohort A

Patients who receive first-line zorifertinib and meet the inclusion/exclusion criteria of the EVEREST study (the EVEREST study is a randomized, open-label, multi-center, Phase II/III study to compare the efficacy and safety of first-line zorifertinib versus gefitinib/erlotinib in EGFR-mutant advanced NSCLC patients with CNS metastases)

Drug: zorifertinib

Cohort B

Patients who receive first-line zorifertinib but do not meet the inclusion/exclusion criteria of the EVEREST study (the EVEREST study is a randomized, open-label, multi-center, Phase II/III study to compare the efficacy and safety of first-line zorifertinib versus gefitinib/erlotinib in EGFR-mutant advanced NSCLC patients with CNS metastases)

Drug: zorifertinib

Cohort C

Patients who receive various other anti-tumor drugs selected by the clinician, excluding zorifertinib, as first-line treatment.

Interventions

zorifertinibDrug

Cohort A and B will receive zorifertinib as first line treatment

Cohort ACohort B

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Male or female, aged ≥18 years.

Sponsors & Collaborators

Alpha Biopharma (Jiangsu) Co., Ltd.
Industrylead

Study Sites (34)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

NOT_YET_RECRUITING

Yingying Du Associate ProfessorCONTACT13956012561 duyingying@126.com

Beijing Tumor Hospital

Beijing, Beijing Municipality, 100000, China

NOT_YET_RECRUITING

Jun Zhao ProfessorCONTACT13521469355

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Yilong Wu M.D.
Guangdong Provincial People's Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

John Ge M.D.

CONTACT

+86 (0)21-63862197 john.ge@alphabiopharma.com.cn

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 27, 2025

Study Start

December 29, 2025

Actual (reported)

Primary Completion

May 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

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).
Other reasons that, in the Investigator's opinion, make the patient unsuitable for this study.
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.
ECOG performance status 0 or 1, with no deterioration over the past 2 weeks, and expected survival time ≥ 3 months.
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.
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.
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).
Positive for T790M mutation documented by central or local laboratory using an approved or validated test method, or documented positive KRAS or cMET.
Patients who have received any investigational drug, biological therapy, or immunotherapy for their malignant tumors within the past 21 days.
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.
Presence of only leptomeningeal metastases (LM) disease confirmed by MRI and/or positive cerebrospinal fluid (CSF) pathology, with no brain metastases (BM).
Prior radiation therapy for CNS metastases that involves measurable or non-measurable sites of disease to assess efficacy.
+31 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (2)

Study Arms (3)

Cohort A

Cohort B

Cohort C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (34)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (2)

Study Arms (3)

Cohort A

Cohort B

Cohort C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (34)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations