Clinical trial · Interventional
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation
NCT02960607CI-TRIAL-00024833unknownPhase 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 investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib
- description
- 250mg, tid until disease progression or unacceptable toxicities occurred
- interventionNames
- Drug: Icotinib
Primary outcomes (1)
- measure
- Progression Free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage IIIB/IV NSCLC * Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment * Patients whose tumors: * are EGFR mutation-positive or * T790M mutation-negative * Performance status: WHO 0-2 * Measurable disease according to RECIST 1.1 * at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology * a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm * ANC ≥ 1.5\*109/L, Platelets ≥ 75\*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (\< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN * Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures * Patient must be able to comply with the protocol Exclusion Criteria: * Patient with symptomatic central nervous system metastases * Patient has known active hepatitis B or C, or HIV infection * Pregnant or breastfeeding. * Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
References
Publications (0)
Data not yet available
No reference posted for this study.