Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI

ConditionsNSCLC (Non-small Cell Lung Carcinoma)Leptomeningeal Metastasis EGFR-TKI Sensitizing Mutation Zorifertinib

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

A Prospective Study of Zorifertinib Combined with Intra-Ommaya Reservoir Cerebrospinal Fluid Chemotherapy for Leptomeningeal Progression in NSCLC Patients After Third-Generation EGFR-TKI Therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Have fully understood the study and voluntarily signed the Informed Consent Form (ICF).

Neutrophil count ≥ 1.5 × 10⁹/L

Platelet count ≥ 100 × 10⁹/L

Hemoglobin ≥ 90 g/L

Disqualifiers

1. Subjects with a history of cranial or spinal radiotherapy within 6 months prior to study drug administration are ineligible for enrollment. Radiotherapy for bone metastases within 3 months prior to study drug administration is also not permitted.

Myocardial infarction within 6 months prior to screening;

Documented history of heart failure (NYHA Class III-IV);

Uncontrolled hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, regardless of antihypertensive medication use (adjustment of antihypertensive drugs prior to screening is permitted);

Trial design

Design model

Single group

Treatments tested in this trial

Zorifertinib Plus Intra-Ommaya CSF Chemotherapy
Drug
Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI Therapy

Treatment groups

38 Participants

are divided into 1 treatment group

Group A: Zorifertinib Plus Intra-Ommaya CSF ChemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Response Assessment in Neuro - Oncology Leptomeningeal Metastases (RANO - LM) criteria

RANO-LM uses a categorical classification (no single numeric score range) to define disease status: Complete Response (CR): All LM-related lesions disappear, no increase in ventricular size. Partial Response (PR): All measurable LM nodules shrink by ≥50% (sum of perpendicular diameters), no increase in ventricular size. Stable Disease (SD): Neither PR nor Progressive Disease (PD) criteria are met. Progressive Disease (PD): Any of the following: 1. New measurable LM nodule(s); 2. ≥50% increase in the product of perpendicular diameters of any measurable nodule (≥25% if the largest diameter is \<10mm); 3. ≥25% increase in Evan's index (marker of hydrocephalus progression); 4. New linear meningeal enhancement (excluding post-lumbar puncture changes).

Time frame

Until the end of the study (up to 3 years)

Secondary outcomes

Overall Survival (OS)

Time frame

Until the end of the study (up to 3 years)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Alpha Biopharma (Jiangsu) Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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