NCT06663306 Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC
| NCT ID | NCT06663306 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Chest Hospital |
| Condition | Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 19 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 19 participants in total. It began in 2024-12-09 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 efficacy 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 aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN ; Creatinine≤ 2.0 × ULN,or Creatinine clearance rate (CrCl) ≥ 50 mL/min; * 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 prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study; * Understand and sign the informed consent form. Exclusion Criteria: * 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: 1. Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy; 2. Urine protein≥2+,or 24-hour urine protein≥2g； 3. Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia; 4. Major hemoptysis within the past 1 month; History of coagulation disorders; 5. Presence of serious non-healing wounds, ulcers, or bone fractures 6. Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction; 7. Presence of macrovascular invasion； 8. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06663306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06663306 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06663306 currently recruiting?
Yes, NCT06663306 is actively recruiting participants. Contact the research team at eddiedong8@hotmail.com for enrollment information.
Where is the NCT06663306 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06663306 clinical trial?
NCT06663306 is sponsored by Shanghai Chest Hospital. The trial plans to enroll 19 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.