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High-Dose Firmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed in the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

NCT06971406 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-14

No results posted yet for this study

Summary

Primary Objective:

To evaluate the efficacy of high-dose firmonertinib combined with bevacizumab and intrathecal pemetrexed in EGFR Ex19del/L858R-mutated non-small cell lung cancer (NSCLC) with leptomeningeal metastasis (LM), as measured by Overall Survival (OS).

Secondary Objectives:

1. To assess the efficacy of this regimen in EGFR Ex20ins/PACC/L861Q-mutated NSCLC with LM.
2. To further evaluate therapeutic outcomes across cohorts, including:

* Time to Treatment Failure (TTF)
* Leptomeningeal Objective Response Rate (ORR-LM)
* Clinical Response Rate
3. To analyze the impact of this regimen on \*quality of life\* using standardized metrics:

* EORTC QLQ-C30
* EORTC QLQ-LC13
4. To assess safety profiles across cohorts, focusing on:

* Incidence and severity of adverse events (AEs) graded per \*CTCAE v5.0\*
* Frequency of treatment-related toxicities

Exploratory Objectives:

To investigate correlations between dynamic changes in:

* Plasma-derived circulating tumor DNA (ctDNA)
* Cerebrospinal fluid-derived cell-free DNA (cfDNA) and clinical outcomes through comparative analysis of genomic profiling and epigenetic signatures before and after treatment.

Conditions

  • Non Small Cell Lung Cancer
  • EGFR Mutation
  • Leptomeningeal Metastases
  • Targeted Therapy

Interventions

DRUG

Combination therapy prospective cohort

high-dose firmonertinib (240 mg, daily), bevacizumab (15 mg/kg, every 3 weeks), and pemetrexed (50 mg, intrathecal chemotherapy C1d1d5, then every 3 weeks)

Sponsors & Collaborators

  • Qiming Wang

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2027-01-01
Completion
2027-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06971406 on ClinicalTrials.gov