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Trial Title:
Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases
NCT ID:
NCT06440954
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
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
Description:
Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction
treatment, then once monthly until progressive disease.
Arm group label:
Intrathecal pemetrexed
Other name:
pemetrexed
Summary:
This is a prospective interventional study clinical study to investigate the efficacy and
resistance mechanisms of intrathecal pemetrexed in patients with driver gene mutations
advanced NSCLC with leptomeningeal metastases.
Detailed description:
This is a prospective interventional clinical study aimed at investigating the efficacy
and resistance mechanisms of intrathecal pemetrexed in advanced NSCLC patients with EGFR,
ALK, and ROS1 mutations presenting leptomeningeal metastases. Approximately 30 advanced
NSCLC patients with EGFR, ALK, and ROS1 mutations, who have developed leptomeningeal
metastases following TKI resistance, will receive intrathecal pemetrexed. Cerebrospinal
fluid samples will be collected before and after pemetrexed resistance to analyze
molecular mechanisms and differences. Second-generation gene detection will be performed
to identify potential resistance mechanisms to pemetrexed. The study is expected to
commence recruitment in mainland China around April 2024, with an anticipated completion
date in April 2025.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Histopathology or cytology confirmed metastatic non-small cell lung cancer with
leptomeningeal metastasis after TKI resistant.
3. EGFR mutant, ALK fusion, ROS1 fusion, and other oncogenic alterations including RET
fusion, BRAF mutation, NTRK fusion, KRAS mutation was confirmed by an accredited
local laboratory.
4. Adequate bone marrow hematopoiesis and organ function
5. Agree to receive intrathecal pemetrexed
6. ECOG 0 - 2.
7. Predicted survival ≥ 12 weeks.
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 or meningeal metastasis.
4. History of other malignant tumors within 2 years.
5. Adverse events (except alopecia of any degree) of CTCAE > grade 1 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 sunvozertinib or anlotinib 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
Status:
Recruiting
Contact:
Last name:
Yongchang Zhang, MD
Phone:
+86 731 89762323
Email:
zhangyongchang@csu.edu.cn
Contact backup:
Email:
zhangyongchang@csu.edu.cn
Investigator:
Last name:
Yongchang Zhang, MD
Email:
Principal Investigator
Start date:
May 1, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer 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/NCT06440954
