Status:
UNKNOWN
Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
Lead Sponsor:
West China Hospital
Conditions:
NSCLC Associated With Leptomeningeal Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 t...
Eligibility Criteria
Inclusion
- Aged 18-75 years old, male or female;
- Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- Expected survival time of at least 4 weeks;
- Oncologist clarification of the potential necessity of receiving systemic therapy for metastatic tumors outside the CNS;
- 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;
- 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.
- Laboratory test indicators meet the following criteria:
- 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;
- Renal function: Cr ≤ ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr) ≥ 55 ml/min;
- Liver function: total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 2.5; (if there is liver metastasis, total bilirubin is not higher than 3 times the upper limit of normal, and transaminases are not higher than 5 times the upper limit of normal);
- Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 1.5, and partial thromboplastin time within the normal value;
- 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;
- Those who have not participated in another drug clinical trial within 4 weeks prior to enrollment;
- Subjects who can understand the study situation and voluntarily sign the informed consent form;
- Patients are expected to be compliant and able to follow up on efficacy and adverse events according to protocol requirements.
Exclusion
- Diagnosis of other malignant tumors (except carcinoma in situ, basal cell carcinoma, etc.) within the previous 5 years;
- History of allergy to pemetrexed and ICIs therapy;
- Any previous intrathecal injection therapy;
- Rule out differential diagnosis of LM:a. Aseptic meningitis b. Viral meningitis c. Bacterial meningitis;
- Participation in other clinical trials or observation periods;
- 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;
- 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);
- 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.
- Either disease resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy;
- Presence of active infection or serious comorbidities;
- uncontrolled epilepsy, neurologic failure, or severe neurologic impairment related to treatment;
- Presence of hereditary or acquired bleeding and thrombotic tendencies;
- History of severe injury or surgery within 1 month prior to enrollment;
- Treatment with a live or attenuated vaccine used for the prevention of infectious diseases within 30 days prior to the first administration (injectable seasonal influenza vaccine is permitted);
- Inability to complete an enhanced MRI;
- Treatment with immunosuppressive drugs or corticosteroids (\> 10 mg prednisone or equivalent per day) within 14 days prior to enrollment; patients are allowed to receive steroid therapy to control CNS-related symptoms, but the dose must ≤ 5 mg per day of dexamethasone (or equivalent); in the absence of an active autoimmune disease, inhaled or topical steroids and adrenal gland replacement dosing are acceptable; alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are permitted; patients with experimental medications that require premedication with corticosteroids are not restricted;
- Individuals considered by the investigator to be unsuitable for enrollment.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06132698
Start Date
November 30 2023
End Date
November 30 2025
Last Update
November 24 2023
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