Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases

NCT06440954 | Recruiting Phase 2

• 1 other identifier: 20240442
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Intracranial progression-free survival (I-PFS)

  Intracranial progression-free survival was defined as the duration from the start of IP to the worsening of neurological symptoms, radiological confirmation of brain progression, or patient death

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

Secondary Outcomes (1)

• System progression-free survival (s-PFS)

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

Other Outcomes (1)

• Overall Survival Time

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

Study Arms (1)

Intrathecal pemetrexed

EXPERIMENTAL

Intrathecal pemetrexed

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

Intrathecal pemetrexed

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Histopathology or cytology confirmed metastatic non-small cell lung cancer with leptomeningeal metastasis after TKI resistant.
• 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.
• Adequate bone marrow hematopoiesis and organ function
• Agree to receive intrathecal pemetrexed
• ECOG 0 - 2.
• Predicted survival ≥ 12 weeks.

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
• Hunan Cancer Hospital: collaborator

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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

Study Officials

• Yongchang Zhang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Yongchang, professor

CONTACT

13873123436; zhanglei1152@126.com

Liang Zeng

CONTACT

15974139200; 530490930@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: June 4, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

CN (1)