Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metastatic

NCT ID: NCT06497543

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-04-30

Brief Summary

This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis.

Detailed Description

This is a prospective interventional clinical study to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis. Approximately 80 small cell lung cancer patients with refractory brain and/or leptomeningeal metastasis were enrolled and treated with intrathecal pemetrexed, there were 40 cases in cohort 1 with refractory brain metastasis and 40 cases in cohort 2 with leptomeningeal metastasis.Cerebrospinal fluid samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms. The study is expected to commence recruitment in mainland China in about September 2024. It is expected that the trial will end in April 2026.

Conditions

Small-cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Small Cell Lung Cancer patient with Refractory Brain Metastases

Group Type: EXPERIMENTAL

Intrathecal Pemetrexed

Intervention Type: DRUG

Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly until progressive disease.

Cohort 2

Small Cell Lung Cancer patient with Leptomeningeal Metastasis

Group Type: EXPERIMENTAL

Intrathecal Pemetrexed

Intervention Type: DRUG

Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly until progressive disease.

Interventions

Intrathecal Pemetrexed

Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly until progressive disease.

Intervention Type: DRUG

Other Intervention Names

Pemetrexed

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second People's Hospital of Hunan

OTHER

Sponsor Role: collaborator

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongchang Zhang

Head of Medical Oncology, Director of Early Clinical Trial Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yongchang Zhang

Changsha, Hunan, China

Countries

China

Central Contacts

Yongchang Zhang, MD

Role: CONTACT

zhangyongchang@csu.edu.cn

+8613873123436

Liang zeng, MD

Role: CONTACT

15974139200

Other Identifiers

20240705

Identifier Type: -

Identifier Source: org_study_id