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Trial Title:
Intrathecal Pemetrexed Combined With High-dose Furmonertinib and Beva for EGFR-m NSCLC With Leptomeningeal Metastases
NCT ID:
NCT06537297
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Bevacizumab
Pemetrexed
Aflutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Intrathecal Pemetrexed and high-dose Furmonertinib plus bevacizumab
Description:
- Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction
treatment, then once monthly;
- Furmonertinib(160mg QD);
- bevacizumab(5mg/kg，once monthly) until progressive disease.
Arm group label:
Intrathecal Pemetrexed with double Furmonertinib plus bevacizumab
Other name:
intrathecal pemetrexed, high-dose furmonertinib, bevacizumab
Summary:
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with
high-dose Furmonertinib plus bevacizumab for EGFR-mutant non-small cell lung cancer
patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs.
Detailed description:
This prospective interventional study aimed to evaluate the efficacy and safety of
intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant
NSCLC patients with leptomeningeal metastases after resistance to third-generation
EGFR-TKIs.
Approximately 30 EGFR-mutant Non-small cell lung cancer patients with leptomeningeal
metastasis or leptomeningeal progression after resistant to third generation EGFR-TKIs
were enrolled and treated with intrathecal pemetrexed with high-dose furmonertinib plus
bevacizumab. cerebrospinal fluid and blood samples will be collected before and after
pemetrexed resistance to analyze molecular mechanisms. Second-generation gene detection
will be performed to identify potential resistance mechanisms to pemetrexed. The study is
expected to commence recruitment in mainland China in about August 2024. It is expected
that the trial will end in April 2026.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Understand the requirements and contents of the clinical trial, and provide a
signed and dated informed consent form.
-
2. Age ≥ 18 years.
-
3. Histopathology confirmed Non-small cell lung cancer.
-
4. confirmed or probable leptomeningeal metastases according to EANO-ESMO
guidelines or known leptomeningeal metastases progression after third
generation of EGFR-TKIs failure.
- 5.Leptomeningeal metastasis (LM) is defined by the presence of typical clinical
symptoms, positive cerebrospinal fluid (CSF) cytology, detection of cell-free DNA
(cfDNA) in CSF by next-generation sequencing (NGS), or imaging findings consistent
with typical meningeal metastases.
- 6.ECOG 0 - 2.
-
7. Predicted survival ≥ 12 weeks.
-
8. Adequate bone marrow hematopoiesis and organ function.
Exclusion Criteria:
-
1. Previously received intrathecal pemetrexed therapy for locally advanced or
metastatic disease.
-
2. Subjects who have received any of the following treatments must be excluded:
Have received radiation within 14 days prior to the first dose or have not
recovered from radiation-related toxicity. Chest and extra-brain palliative
radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may
be performed 7 days prior to the first dose.
-
3. Presence of spinal cord compression.
-
4. History of other malignant tumors within 2 years.
-
5. Adverse events (except alopecia of any degree) of CTCAE > grade 4 due to prior
treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first
dose.
-
6. History of stroke or intracranial hemorrhage within 6 months prior to the first
dose.
-
7. The presence of any severe or poorly controlled systemic disease, including
poorly controlled hypertension and active bleeding in the judgment of the
investigator.
-
8. Subjects with persistent or active infection, including but not limited to
hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and
COVID-19 infection.
-
9. Heart-related diseases or abnormalities
-
10. Past history of interstitial lung disease, drug-induced interstitial lung
disease, radiation pneumonitis requiring steroid therapy or interstitial lung
disease with active clinical symptoms, immune pneumonia caused by
immunotherapy.
-
11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty
swallowing drugs, or inability to adequately absorb Furmonertinib due to
previous bowel resection.
-
12. Live vaccine was given 2 weeks before the first medication.
-
13. Women who are breastfeeding or pregnant.
-
14. Hypersensitivity to the test drug and the ingredients.
-
15. Other conditions assessed by the investigator to be unsuitable for
participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Contact:
Last name:
Yongchang Zhang, MD
Phone:
+86 731 89762323
Email:
zhangyongchang@csu.edu.cn
Start date:
September 30, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06537297
