Clinical trial · Interventional
A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy
A Multi-center, Prospective Study to Determine the Efficiency of Icotinib Combined With Radiation Therapy Early Intervention or Late Intervention For NSCLC Patients With Brain Metastases and EGFR(Epidermal Growth Factor Receptor) Mutation
NCT04058704CI-TRIAL-00040085SMARTunknownPhase 3ClinicalTrials.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 alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .
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 |
| SRS/WBRT/HA-WBRT/SMART | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early intervention
- description
- Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally.
- interventionNames
- Drug: Icotinib
- Radiation: SRS/WBRT/HA-WBRT/SMART
- type
- EXPERIMENTAL
- label
- Late intervention
- description
- Icotinib is administered orally three times per day. Until emerge the progression of the disease, then is given radiation therapy (SRS/WBRT/HA-WBRT/SMART)
- interventionNames
- Drug: Icotinib
- Radiation: SRS/WBRT/HA-WBRT/SMART
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) * Positive EGFR mutation(Ex19del or 21L858R) * Primary diagnosis of brain metastases * Have one or more measurable encephalic lesions according to RECIST * Extracranial transfer organ≤3 * ECGO:0-2 * Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. * Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min. * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and -Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases. * Female subjects should not be pregnant. * All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications. * Written informed consent provided. Exclusion Criteria: * Previous usage of EGFR-TKI : gefitinib, erlotinib, icotinib,or any other TKI * CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal. * Allergic to Icotinib. * Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. * Pregnancy or breast-feeding women. * Participate in the other anti-tumor clinical trials in 4 weeks. have quit from the trail before. * Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
References
Publications (0)
Data not yet available
No reference posted for this study.