Loading clinical trials...

Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC

Efficacy and Safety of Immune Checkpoint (PD-1) Inhibitor Combined With Pemetrexed Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC

NCT06132698•West China Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, open clinical study, which was designed to evaluate the efficacy and safety of an immune checkpoint inhibitor combined with pemetrexed intrathecal injection in the treatment of patients with NSCLC associated with leptomeningeal metastases.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Aged 18-75 years old, male or female;
•2. Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis;
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
•4. Expected survival time of at least 4 weeks;
•5. Oncologist clarification of the potential necessity of receiving systemic therapy for metastatic tumors outside the CNS;
•6. Previous radiation therapy, including whole brain radiation, stereotactic radiosurgery, or stereotactic body radiation therapy (SBRT), which must be completed at least 7 days prior to the start of treatment;
•7. Patients who have received approved targeted therapies (EGFR inhibitors, ALK inhibitors, or other targeted therapeutic agents), and other systemic therapies will be allowed to remain on concurrent therapy; concurrent intrathecal therapy with other agents will not be allowed.
•8. Laboratory test indicators meet the following criteria:
•1. Bone marrow function: hemoglobin (Hb) ≥80g/L; white blood cell count (WBC) ≥lower limit of normal; absolute neutrophil count (ANC) ≥1.5×10\^9 /L; platelet count ≥70×109 /L;
•2. Renal function: Cr ≤ ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr) ≥ 55 ml/min;
+6 more criteria

Exclusion Criteria

•1. Diagnosis of other malignant tumors (except carcinoma in situ, basal cell carcinoma, etc.) within the previous 5 years;
•2. History of allergy to pemetrexed and ICIs therapy;
•3. Any previous intrathecal injection therapy;
•4. Rule out differential diagnosis of LM:a. Aseptic meningitis b. Viral meningitis c. Bacterial meningitis;
•5. Participation in other clinical trials or observation periods;
•6. Clinical conditions that would interfere with the evaluation or interpretation of safety or findings, or impede the understanding of informed consent and compliance with protocol requirements;
•7. Presence of any treatment-related toxicity from prior systemic antitumor therapy other than alopecia that does not meet CTCAE grade 1 (based on CTCAE 5.0);
•8. Presence of any active autoimmune disease or history of autoimmune disease; immunodeficiency, active tuberculosis, hepatitis B ( hepatitis B virus titer HBV-DNA \<500 IU/ml after treatment and if liver function is normal will be allowed), or positive test for hepatitis C virus.
•9. Either disease resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy;
•10. Presence of active infection or serious comorbidities;
+7 more criteria

Key Dates

Start Date

November 30, 2023

Primary Completion Date

November 30, 2024

Completion Date

November 30, 2025

Last Updated

November 24, 2023

Enrollment

ESTIMATED participants

Conditions

NSCLC Associated With Leptomeningeal Metastases

Interventions

Tislelizumab, pemetrexed

DRUG