Clinical trial · Interventional
High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases
A Phase II Study to Determine the Efficacy and Safety of High Dose Icotinib Combined With Stereotatic Radiosurgery for NSCLC Patients Harboring EGFR Mutation With Brain Metastases
NCT02726568CI-TRIAL-00037169unknownPhase 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)
This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.
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 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib 375mg Tid
- description
- The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction.
- interventionNames
- Drug: Icotinib
- Radiation: SRS
Primary outcomes (1)
- measure
- intracranial progression-free survival
- timeFrame
- from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.
Secondary outcomes (5)
- measure
- progress-free survival
- timeFrame
- from date of randomization until the date of extracranial progression, assessed up to 18 months.
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. * Less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm. * Positive EGFR mutation(Ex19del or 21L858R). * Life expectancy ≥3months. * Have one or more measurable encephalic lesions according to RECIST. * The patient has not received radiotherapy for the head or extracranial target lesions before. * 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 or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux. * 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.