Clinical trial · Interventional
Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
NCT01514877CI-TRIAL-00015170completedPhase 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 aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib plus Whole Brain Radiotherapy
- description
- Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM). Icotinib is a new first generation EGFR-TKI. We conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with whole brain radiotherapy (WBRT) in Chinese NSCLC patients with BM and investigated the cerebrospinal fluid (CSF)/ plasma concentrations of icotinib.
- interventionNames
- Drug: Icotinib
Primary outcomes (1)
- measure
- partial response rate of intracranial lesions
- timeFrame
- 2 years
- description
- Partial response rate of intracranial lesions will be measured.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologic or histological diagnosis of non-small cell lung cancer * Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated * Patients are diagnosed with multiple brain metastases for the first time in 4 weeks * Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI). * Doctors consider the patient will benefit from WBRT * No prior brain radiotherapy * ECOG performance status 0-2 * age:18-75 years * Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L * Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement) * Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) * Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study Exclusion Criteria: * Prior brain radiation therapy * Solitary brain metastasis according to Magnetic resonance imaging (MRI) * Mort than 3 extracranial organs have metastatic lesions * Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible). * pregnant or breast feeding women
References
Publications (1)
- DERIVEDFan Y, Huang Z, Fang L, Miao L, Gong L, Yu H, Yang H, Lei T, Mao W. A phase II study of icotinib and whole-brain radiotherapy in Chinese patients with brain metastases from non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Sep;76(3):517-23. doi: 10.1007/s00280-015-2760-5. Epub 2015 Jul 7. PMID 26148750