NSCLC Associated With Leptomeningeal MetastasesPhase 2NCT06132698
Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
A Phase 2 study testing Tislelizumab or pembrolizumab, pemetrexed in people with NSCLC Associated With Leptomeningeal Metastases, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NSCLC Associated With Leptomeningeal Metastases
- What is being tested?
- Tislelizumab or pembrolizumab, pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 4;
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ting Liu, 19182843926, 1924658083@qq.com
About this study
Official title: Efficacy and Safety of Immune Checkpoint (PD-1) Inhibitor Combined With Pemetrexed Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
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.
- Being tested
- Tislelizumab or pembrolizumab, pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab or pembrolizumab, pemetrexedDrug
Drug 1: Tislelizumab/pembrolizumab 50 mg; Drug 2: pemetrexed 20mg. intrathecal injection therapy
| Study group | Role | What they receive |
|---|---|---|
| Enrolled patients were treated with an immune checkpoint inhibitor combined with pemetrexed intrathe | Experimental | Not described Receives: Drug: Tislelizumab or pembrolizumab, pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (LM ORR) for leptomeningeal metastases.
Defined as the response to treatment as assessed by the investigator based on the modified Response Assessment in Neuro-Oncology Leptomeningeal Metastases (RANO-LM) criteria, containing cases of complete response, partial response, and major response.
Measured: 12 months.
Secondary outcomes (5)
Median Progression-Free Survival (CNS-PFS) in the Central Nervous System.
Progression-free survival will be measured as time to radiologic, cytologic, or LM-related clinical progression.
Measured: Time from the start of intrathecal therapy to radiologic, cytologic, or LM-related clinical progression, whichever outcome occurs first, assessed up to 12 months.
Progression-Free Survival (PFS).
Progression-free survival will be measured as time to either progression or death.
Measured: Time from the first day of administration of study drug until the first efficacy assessment of disease progression (PD) or death from any cause, assessed up to 12 months.
Overall survival (OS).
Overall survival will be measured as time to death from any cause.
Measured: Time from the date of randomisation to the date of death from any cause, assessed up to 12 months.
Disease Control Rate (DCR).
The DCR was defined as the proportion of patients with the best efficacy (complete response or partial response or stable disease).
Measured: 12 months.
Adverse events.
toxicity values caused by intrathecal injection treatment.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start30 Nov 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Associated With Leptomeningeal MetastasesStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132698
- Sponsor's protocol ID
- West China Hospital of SU
- Status last verified
- May 2026
- First submitted
- 7 Nov 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Immune Checkpoint (PD-1) Inhibitor Combined With Pemetrexed Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
- ClinicalTrials.gov ID
- NCT06132698
- Acronym / sponsor ID
- West China Hospital of SU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients were treated with an immune checkpoint inhibitor combined with pemetrexed intrathe | Experimental | Drug: Tislelizumab or pembrolizumab, pemetrexed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 4;
- Expected survival time of at least 4 weeks;
- Oncologist clarification of the potential necessity of receiving systemic therapy for metastatic tumors outside the CNS;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab or pembrolizumab, pemetrexedDrug 1: Tislelizumab/pembrolizumab 50 mg; Drug 2: pemetrexed 20mg. intrathecal injection therapy | Drug | Enrolled patients were treated with an immune checkpoint inhibitor combined with pemetrexed intrathe |
Primary outcome
Objective response rate (LM ORR) for leptomeningeal metastases.
Time frame: 12 months.
Defined as the response to treatment as assessed by the investigator based on the modified Response Assessment in Neuro-Oncology Leptomeningeal Metastases (RANO-LM) criteria, containing cases of complete response, partial response, and major response.
5 secondary outcomes
Median Progression-Free Survival (CNS-PFS) in the Central Nervous System.
Time frame: Time from the start of intrathecal therapy to radiologic, cytologic, or LM-related clinical progression, whichever outcome occurs first, assessed up to 12 months.
Progression-Free Survival (PFS).
Time frame: Time from the first day of administration of study drug until the first efficacy assessment of disease progression (PD) or death from any cause, assessed up to 12 months.
Overall survival (OS).
Time frame: Time from the date of randomisation to the date of death from any cause, assessed up to 12 months.
Disease Control Rate (DCR).
Time frame: 12 months.
Adverse events.
Time frame: 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab or pembrolizumab, pemetrexed in people with NSCLC Associated With Leptomeningeal Metastases, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (LM ORR) for leptomeningeal metastases. (time frame: 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.