NCT06440954 Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases
| NCT ID | NCT06440954 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hunan Province Tumor Hospital |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2024-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Yongchang Zhang
PRINCIPAL INVESTIGATOR
Hunan Cancer Hospital
Frequently Asked Questions
Who can join the NCT06440954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06440954 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06440954 currently recruiting?
Yes, NCT06440954 is actively recruiting participants. Contact the research team at zhanglei1152@126.com for enrollment information.
Where is the NCT06440954 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06440954 clinical trial?
NCT06440954 is sponsored by Hunan Province Tumor Hospital. The principal investigator is Yongchang Zhang at Hunan Cancer Hospital. The trial plans to enroll 220 participants.
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