Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metast… (NCT06497543) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metastatic
China80 participantsStarted 2024-10-01
Plain-language summary
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis.
Who can participate
Age range18 Years
SexALL
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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 is confirmed small cell lung cancer .
* 4.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.
* 5.Patients with brain progression after whole-brain radiotherapy.
* 6\. Predicted survival ≥ 12 weeks. .
* 7\. ECOG 0-2.
* 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 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 int…
What they're measuring
1
Overall Survival
Timeframe: Time from first subject dose to study completion, or up to last follow up