Central Nervous System (CNS) Metastases, EGFR Mutant Advanced Non-small Cell Lung Cancer
Conditions
Brief summary
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).
Interventions
DRUGzorifertinib
Cohort A and B will receive zorifertinib as first line treatment
Sponsors
Alpha Biopharma (Jiangsu) Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | up to 36 months | The period from the first administration date of the study treatment to the date of death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) for zorifertinib | up to 36 months | All adverse events were classified according to the CTCAE (version: 5.0) |
| Incidence of Dose Adjustments for zorifertinib | up to 36 months | The dose adjustments during the treatment by zorifertinib |
| Progression-free survival (PFS) | every 8 weeks,up to 36 months | Investigator conducted the assessment based on RECIST 1.1 |
| intracranial Progression-free survival (iPFS) | every 8 weeks,up to 36 months | Investigator conducted the assessment based on RECIST 1.1 |
| Objective Response Rate (ORR) | every 8 weeks, up to 36 months | Investigator conducted the assessment based on RECIST 1.1 |
Countries
China
Contacts
CONTACTJohn Ge M.D.
PRINCIPAL_INVESTIGATORYilong Wu M.D.
Guangdong Provincial People's Hospital
Outcome results
None listed