Clinical trial · Interventional
Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation.
NCT01516983CI-TRIAL-00013780completedPhase 1 / Phase 2ClinicalTrials.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 evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.
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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| icotinib | Drug | Icotinib | ALIAS |
| Whole brain radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib+WBRT
- description
- Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
- interventionNames
- Drug: icotinib
- Radiation: Whole brain radiotherapy
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- 6-12 months
- description
- All cause adverse events (AEs) and serious adverse events (SAEs)
Secondary outcomes (6)
- measure
- Neurological progression-free survival
- timeFrame
- 3-6 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmation of non-small cell lung cancer (NSCLC). * Diagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm. * Positive EGFR mutation. Exclusion Criteria: * Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux. * CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
References
Publications (0)
Data not yet available
No reference posted for this study.