Central Nervous System Metastasis, EGFR Positive Non-small Cell Lung Cancer, Leptomeningeal Metastasis
Conditions
Brief summary
This is a clinical retrospective study that will collect and analyze clinical data from all patients treated with fumeitinib mesylate in the Oncology Department of Tiantan Hospital between January 1, 2020 and May 31, 2025. The data collection will include general demographic characteristics (gender, age, family history, smoking history, etc.), clinicopathological features, NGS test reports, fumeitinib initiation time and dosage, concomitant medications, local treatments (surgery, radiotherapy, etc.), and baseline and follow-up imaging examinations related to efficacy and safety. The study will conduct: 1) clinical data analysis; and 2) exploration of resistance-related clinical characteristics and influencing factors.
Interventions
DRUGFirmonertinib
Firmonertinib any dose, oral
Sponsors
Beijing Tiantan Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed stage IIIb-IVb NSCLC or postoperative recurrent NSCLC; 2. Positive EGFR test result, which can be determined by methods such as RT-PCR/FISH/IHC/NGS from hospital laboratories or testing institutions; 3. Patients aged ≥18 years; 4. Patients have clinically received Firmonertinib treatment, with recorded objective efficacy evaluation and adverse reactions; 5. Sign the Beijing Tiantan Hospital broad informed consent form.
Exclusion criteria
\- Patients who cannot provide follow-up data for at least one cycle.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iPFS | From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025 | According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the Response Assessment in Neuro-Oncology (RANO) criteria, the intracranial progression-free survival (iPFS) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and EGFR mutation-positive status will be evaluated separately for different cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| iDCR | Within the study period from January 1, 2020 and May 30, 2025 | For different cohorts, evaluate the intracranial objective response rate (iORR) and disease control rate (iDCR) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) positive for EGFR mutations and presenting with central nervous system metastases |
| PFS | From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025 | According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) the progression-free survival (iPFS) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and EGFR mutation-positive status will be evaluated separately for different cohorts |
| OS | From first dose until death, assessed between January 1, 2020 and May 30, 2025 | measured from the date of first-line treatment initiation to the date of documented death |
| DOR | Within the study period from January 1, 2020 and May 30, 2025 | defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria, assessed at the first radiologic evaluation following initiation of treatment |
| TTR | assessed during the study period from January 1, 2020 and May 30, 2025. | Defined as the time from the initiation of treatment to the date of first documented objective response (CR or PR) according to RECIST 1.1 criteria |
Countries
China
Outcome results
None listed