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New treatment option for Lung Cancer (NSCLC)
Official title Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC
ClinicalTrials.gov ID: NCT06663306
What this study is testing
What is Pemetrexed?
Pemetrexed is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases.
- Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM);
- Unsatisfactory how well it works of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received...
- Expected survival time ≥ 1 month;
You likely can't join if
- Positive for human immunodeficiency virus (HIV) ;
- History of allergy to pemetrexed or bevacizumab;
- History of pemetrexed and/or bevacizumab intrathecal Injection;
- Presence of contraindication of bevacizumab:
- Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy;
- Urine protein≥2+,or 24-hour urine protein≥2g；
See the full eligibility criteria
- Age ≥ 18 years;
- ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases.
- Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM);
- Unsatisfactory how well it works of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment;
- Expected survival time ≥ 1 month;
- The laboratory test results meet the following criteria:Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine...
- Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days...
- Understand and sign the informed consent form.
- Positive for human immunodeficiency virus (HIV) ;
- History of allergy to pemetrexed or bevacizumab;
- History of pemetrexed and/or bevacizumab intrathecal Injection;
- Presence of contraindication of bevacizumab:
- Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy;
- Urine protein≥2+,or 24-hour urine protein≥2g；
- Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia;
- Major hemoptysis within the past 1 month; History of coagulation disorders;
- Presence of serious non-healing wounds, ulcers, or bone fractures
- Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction;
- Presence of macrovascular invasion；
- Some neurological disorders unrelated to tumors，such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis;
- Brain/spinal cord radiation therapy within 1 week before enrollment;
- Pregnant and lactating female;
- Refuse to use contraception during the study period;
- Individuals considered by the investigator to be unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.