Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Phase 4

• Conditions: Leptomeningeal Metastasis
• Interventions: Drug: Recombinant Human Endostatin; Drug: intrathcal methotrexate; Drug: Targeted drugs for non-small cell lung cancer

• Registration Number: NCT04356118
• Lead Sponsor: Hui Bu

Brief Summary

The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-04-18
• Study First Posted: 2020-04-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-23
• Last Update Posted: 2020-05-27
• Study Start: 2020-06
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age over 18 years old
2. Pathologically proven non-small cell lung cancer
3. Karnofsky performance status ≥ 40
4. LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
5. No severe abnormal liver and kidney function;
6. Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Evidence of bleeding diathesis or serious infection
2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
3. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostatin Therapy for NSCLC of LM	intrathcal methotrexate	Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted drugs for non-small cell lung cancer: EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
Endostatin Therapy for NSCLC of LM	Targeted drugs for non-small cell lung cancer	Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted drugs for non-small cell lung cancer: EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
Endostatin Therapy for NSCLC of LM	Recombinant Human Endostatin	Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted drugs for non-small cell lung cancer: EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .

Primary Outcome Measures

Name	Time	Method
Neurological Progression Free Survival	36 months	From the start of treatment until central nervous system metastase progression or death due to any cause
The incidence of adverse reactions	36 months	From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
Leptomeningeal Metastasis Overall survival	36 months	Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	36 months	ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
Neurological assessment	36 months	In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome.
progression-free survival	36 months	Proportion of patients progression-free by investigator assessment per RECIST v1.1
Overall survival	36 months	defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up