Actively Recruiting
Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases
Led by Hunan Province Tumor Hospital · Updated on 2024-06-04
220
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hunan Province Tumor Hospital
Lead Sponsor
H
Hunan Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed metastatic non-small cell lung cancer with leptomeningeal metastasis after resistance to tyrosine kinase inhibitors
- Presence of EGFR mutation, ALK fusion, ROS1 fusion, or other oncogenic alterations such as RET fusion, BRAF mutation, NTRK fusion, or KRAS mutation confirmed by a certified laboratory
- Adequate bone marrow and organ function
- Agree to receive intrathecal pemetrexed treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival time of 12 weeks or longer
You will not qualify if you...
- Previous treatment with intrathecal pemetrexed for locally advanced or metastatic disease
- Radiation therapy within 14 days before the first dose or unresolved radiation-related side effects; chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, or stereotactic body radiotherapy allowed if done at least 7 days before first dose
- Presence of spinal cord compression or meningeal metastasis
- History of other cancers within the past 2 years
- Severe side effects (greater than grade 1) from prior treatments such as chemotherapy or radiotherapy before first dose, except hair loss
- Stroke or brain bleeding within 6 months before first dose
- Severe or poorly controlled systemic diseases including uncontrolled hypertension or active bleeding as judged by the investigator
- Ongoing or active infections including hepatitis B, hepatitis C, HIV, or COVID-19
- Heart disease or abnormalities
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, active interstitial lung disease symptoms, or immune-related pneumonia
- Severe nausea, vomiting, chronic gastrointestinal disease, swallowing difficulties, or inability to absorb study drugs properly due to previous bowel surgery
- Receipt of live vaccine within 2 weeks before first medication
- Pregnant or breastfeeding women
- Known allergy to the study drug or its ingredients
- Any other condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Z
Zhang Yongchang, professor
CONTACT
L
Liang Zeng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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