Clinical trial · Interventional
Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Efficacy and Safety of Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
NCT04356222CI-TRIAL-00045259unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Durvalumab | — | UNRESOLVED | — |
| Leptomeningeal Metastasis | Meningeal Carcinomatosis | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Leptomeningeal Metastasis
- description
- Durvalumab + Intrathecal chemotherapy
- interventionNames
- Drug: Durvalumab
- Drug: methotrexate
Primary outcomes (3)
- measure
- overall survival (OS)
- timeFrame
- 36 months
- description
- OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive
- measure
- Neurological Progression Free Survival(NPFS)
- timeFrame
- 36 months
- description
- NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and Female age 18 or more 2. Pathologically proven non-small cell lung cancer 3. MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid 4. Patients have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. KPS score \<60 2. History of autoimmune diseases 3. With severe hepatic and renal dysfunction 4. Has a history of (non-infectious) pneumonitis that required steroids
References
Publications (0)
Data not yet available
No reference posted for this study.