Investigating intrathecal pemetrexed for advanced lung cancer with brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective interventional study aims to evaluate the efficacy and resistance mechanisms of intrathecal pemetrexed in patients with advanced non-small cell lung cancer (NSCLC) who have leptomeningeal metastases and specific driver gene mutations. Approximately 30 patients will be enrolled, all of whom have experienced resistance to prior targeted therapies. The study will involve collecting cerebrospinal fluid samples before and after treatment to analyze molecular changes and identify potential resistance mechanisms. Recruitment is expected to begin in mainland China in April 2024, with completion anticipated by April 2025.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Yongchang Zhang — Hunan Cancer Hospital
• Study coordinator: Zhang Yongchang, professor
• Email: zhanglei1152@126.com
• Phone: 13873123436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.