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

NCT06497543 | Not Yet Recruiting Phase 2

• 1 other identifier: 20240705
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  OS was defined as the duration from the start of intrathecal pemetrexed to patient death

  Time from first subject dose to study completion, or up to last follow up

Secondary Outcomes (4)

• Intracranial progression-free survival (I-PFS)

  Time from first subject dose to study completion, or up to 36 month

• Intracranial Objective Response Rate (I-ORR)

  Time from first subject dose to study completion, or up to 36 month

• clinical remission rate

  Time from first subject dose to study completion, or up to 36 month

• Adverse events (AEs)

  Time from first subject dose to study completion, or up to 36 month

Study Arms (2)

Cohort 1

EXPERIMENTAL

Small Cell Lung Cancer patient with Refractory Brain Metastases

Drug: Intrathecal Pemetrexed

Cohort 2

EXPERIMENTAL

Small Cell Lung Cancer patient with Leptomeningeal Metastasis

Drug: Intrathecal Pemetrexed

Interventions

Intrathecal Pemetrexed DRUG

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

Also known as: Pemetrexed

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
• \. Age ≥ 18 years.
• \. Histopathology is confirmed small cell lung cancer .
• 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.
• Patients with brain progression after whole-brain radiotherapy.
• \. Predicted survival ≥ 12 weeks. .
• \. ECOG 0-2.
• \. Adequate bone marrow hematopoiesis and organ function.

You may not qualify if:

• \. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.
• \. 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.
• \. Presence of spinal cord compression or meningeal metastasis.
• \. History of other malignant tumors within 2 years.
• \. 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.
• \. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
• \. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
• \. 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.
• \. Heart-related diseases or abnormalities
• \. 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.
• \. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
• \. Live vaccine was given 2 weeks before the first medication.
• \. Women who are breastfeeding or pregnant.
• \. Hypersensitivity to the test drug and the ingredients.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead
• Second People's Hospital of Hunan: collaborator

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Liang zeng, MD

CONTACT

15974139200

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Oncology, Director of Early Clinical Trial Center

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: October 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: April 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)