Clinical trial · Interventional
Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
NCT03754530CI-TRIAL-00035944unknownPhase 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 efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions
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 |
| WBRT or SRS | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Icotinib
- description
- icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(\>3 with WBRT or \<=3 with SRS) after PD
- interventionNames
- Drug: Icotinib
- type
- EXPERIMENTAL
- label
- Icotinib plus radiation therapy
- description
- Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(\>3), or SRS(\<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.
- interventionNames
- Drug: Icotinib
- Radiation: WBRT or SRS
Primary outcomes (1)
- measure
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) with brain metastases * Histological or cytological confirmation of EGRF positive sensitive mutation * Diagnosis of brain metastases on a Gadolinium-enhanced MRI Exclusion Criteria: * Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux * Previous usage of radiation with brain * 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.