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New treatment option for Carcinoma, Non-Small-Cell Lung
Official title Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC
ClinicalTrials.gov ID: NCT05805631
What this study is testing
What is Pemetrexed?
Pemetrexed is an investigational medicine, being studied as a potential treatment for carcinoma, non-small-cell lung.
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
- Leptomeningeal metastasis (LM) is a complication of advanced non-small cell lung cancer (NSCLC). The incidence of LM in NSCLC patients is around 3-5 %, reaching 9.4 % of those with an epidermal growth factor receptor (EGFR) mutation.
- 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 20 and older
You may be able to join if
- At least 20 years of age.
- Patients with metastatic non-squamous NSCLC harboring known EGFR activating mutation and with a diagnosis of probable or confirmed LM by the European...
- Intracranial disease progression after osimertinib use, proved by contrast-enhanced MRI
- Stable extra-cranial disease status, judged by investigators.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 and a minimum life expectancy of 12 weeks
You likely can't join if
- Uncontrolled extra-CNS disease which needs other systemic treatment than EGFR-TKI.
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or Ca \> 12 mg/dL or corrected serum calcium \> ULN). Patients who are...
- Malignancies other than NSCLC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death...
- On chronic systemic steroid therapy more than 20 mg prednisolone per day (or equivalent) or on any other form of immunosuppressive medication
- Has received a live-virus vaccination within 30 days of planned treatment start
See the full eligibility criteria
- At least 20 years of age.
- Patients with metastatic non-squamous NSCLC harboring known EGFR activating mutation and with a diagnosis of probable or confirmed LM by the European Association of Neuro-Oncology-European Society for Medical Oncology...
- Intracranial disease progression after osimertinib use, proved by contrast-enhanced MRI
- Stable extra-cranial disease status, judged by investigators.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 and a minimum life expectancy of 12 weeks
- Normal bone marrow and organ function as defined below:
- Marrow: Hemoglobin ≥9gm/dL, ANC ≥1500/mm3 platelets ≥100,000/mm3
- Hepatic: Serum total bilirubin ≤1.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) ≤3 x ULN.
- Renal: Creatinine clearance (Ccr) ≥45 mL/min.
- For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate (\< 1% per year) when used consistently and...
- Ability to understand and willingness to sign an IRB approved written informed consent document.
- Willing to provide CSF and plasma samples for ctDNA analysis.
- Uncontrolled extra-CNS disease which needs other systemic treatment than EGFR-TKI.
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or Ca \> 12 mg/dL or corrected serum calcium \> ULN). Patients who are receiving denosumab prior to study enrollment must be willing and eligible...
- Malignancies other than NSCLC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS \> 90%) treated with expected curative outcome...
- On chronic systemic steroid therapy more than 20 mg prednisolone per day (or equivalent) or on any other form of immunosuppressive medication
- Has received a live-virus vaccination within 30 days of planned treatment start
- Systemic cytotoxic chemotherapy or major surgery within 2 weeks of the first dose of study medication
- Active infection requiring therapy
- History of Human Immunodeficiency Virus (HIV) infection.
- Hepatitis B carrier: Patients with HBV infection were required to be receiving effective antiviral therapy and have a viral load less than 100 IU/mL at screening
- Active Hepatitis C
- Has received intrathecal chemotherapy within 2 weeks before the start of IP
- Has received whole-brain radiotherapy (WBRT) within 2 weeks before the start of IP
- Uncontrolled epilepsy
- History of allergic reaction to intravenous pemetrexed.
- Severe coagulation abnormality (INR \> 2).
- Severe symptomatic hydrocephalus that requires other treatment modalities other than IP
- Bulky intra-cranial lesion that requires other treatment modalities other than IP
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan, Taiwan
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, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan, Taiwan. 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.