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Tests treatment safety and results for Leptomeningeal Metastasis
Official title A Study of the Safety and Efficacy of Pemetrexed Combined with Nivolumab Via Intraventricular Injection for the Treatment of Refractory Non-squamous Non-small Cell Lung Cancer with Leptomeningeal Metastases
ClinicalTrials.gov ID: NCT06901817
What this study is testing
What is Intraventricular Pemetrexed?
Intraventricular Pemetrexed is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for leptomeningeal metastasis.
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
- The goal of this clinical trial is to learn if the intraventricular injection of Pemetrexed and Nivolumab works to treat refractory non-squamous non-small cell lung cancer with leptomeningeal metastases. The main questions to answer are: Is the combination of Pemetrexed and Nivolumab safe to inject?
- Phase 2: a mid-size study of how well it works
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
- Patients who sign the informed consent form and are willing to complete the study according to the protocol;
- Patients must have radiographic and/or cerebrospinal fluid cytology evidence of leptomeningeal disease (LMD). The diagnosis of non-small cell lung...
- Patients must have an ECOG performance status score of ≤ 2.
- Patients may use steroids to control symptoms related to the central nervous system, but the dose must be ≤ 4 mg of dexamethasone (or equivalent...
- Patients who have received brain and/or spinal radiotherapy, including whole-brain radiation, stereotactic radiosurgery, or SBRT, can be enrolled...
You likely can't join if
- Patients who require a VP shunt due to increased intracranial pressure.
- Patients must not have active autoimmune diseases requiring systemic treatment in the past two years (i.e., using disease-modifying agents...
- people who need systemic treatment within 14 days prior to administration of the study drug, including the use of corticosteroids (\>4 mg daily...
- Patients who have previously received PD-1 and/or anti-CTLA-4 therapy are eligible, unless they are experiencing \> grade 2 side effects from such...
- Patients currently receiving experimental anti-cancer drugs (co-treatment with approved targeted therapies is permitted).
- Patients with a history of other malignancies are eligible if they have appropriately treated basal cell or squamous cell skin cancer, carcinoma in...
See the full eligibility criteria
- Patients who sign the informed consent form and are willing to complete the study according to the protocol;
- Patients must have radiographic and/or cerebrospinal fluid cytology evidence of leptomeningeal disease (LMD). The diagnosis of non-small cell lung cancer must be confirmed, based on histological and/or cytological...
- Patients must have an ECOG performance status score of ≤ 2.
- Patients may use steroids to control symptoms related to the central nervous system, but the dose must be ≤ 4 mg of dexamethasone (or equivalent dose) within 24 hours. The patient's neurological symptoms should remain...
- Patients who have received brain and/or spinal radiotherapy, including whole-brain radiation, stereotactic radiosurgery, or SBRT, can be enrolled, but must have completed radiation therapy at least 7 days before...
- Patients who have received approved systemic treatments may continue the systemic treatment chosen by the researcher. Concurrent use of other drugs for intrathecal treatment is not allowed. For patients who have...
- Patients who have received intrathecal treatment must have had their last treatment at least 7 days before starting the study treatment.
- Patients who have received systemic chemotherapy must have had their last treatment at least 14 days before starting the study treatment.
- Patients who have received approved systemic immunotherapy (such as anti-PD-1, anti-CTLA4) must have had their last treatment at least 2 weeks before starting the study treatment.
- Patients who have received any other investigational drugs must have had their last treatment at least 14 days before starting the study treatment.
- Age ≥ 18 years.
- Able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form.
- Patients must have the organ and bone marrow function defined in Table 1 below.
- No contraindications to the installation of an Ommaya reservoir.
- Criteria for refractory leptomeningeal metastasis:
- Failed first- or second-generation TKI treatment, T790M mutation-negative;
- Failed third-generation TKI treatment;
- EGFR gene mutation-negative, failed first-line treatment.
- Patients who require a VP shunt due to increased intracranial pressure.
- Patients must not have active autoimmune diseases requiring systemic treatment in the past two years (i.e., using disease-modifying agents, corticosteroids, or immunosuppressive drugs). Alternative therapies (such as...
- people who need systemic treatment within 14 days prior to administration of the study drug, including the use of corticosteroids (\>4 mg daily dexamethasone equivalent dose) or other immunosuppressive drugs. Inhaled or...
- Patients who have previously received PD-1 and/or anti-CTLA-4 therapy are eligible, unless they are experiencing \> grade 2 side effects from such treatments. Ongoing physiological replacement doses for adrenal and...
- Patients currently receiving experimental anti-cancer drugs (co-treatment with approved targeted therapies is permitted).
- Patients with a history of other malignancies are eligible if they have appropriately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancers with no evidence of disease for...
- Participation in another clinical trial within 30 days prior to randomization, receiving investigational drugs and any concomitant treatments containing investigational drugs.
- Immunodeficiency, HIV infection;
- Severe dysfunction of the heart, lungs, liver, or kidneys;
- Uncontrolled infection or active infection;
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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, Shanghai Municipality, 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.