Clinical trial · Interventional
Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
NCT01720901CI-TRIAL-00018001suspendedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual limitations
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | 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
- Icotinib will be administered 250 mg one time by month, 3 times per day.
- interventionNames
- Drug: Icotinib
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 4.5 months
- description
- Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC. * Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib. * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors. * Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: * Allergic to icotinib. * Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab. * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.