Clinical trial · Interventional
Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
NCT01744925CI-TRIAL-00025823unknownPhase 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 study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib of high dose | Drug | — | UNRESOLVED |
| Icotinib of routine dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Icotinib of routine dose
- description
- Icotinib: 125mg, oral administration, three times per day.
- interventionNames
- Drug: Icotinib of routine dose
- type
- EXPERIMENTAL
- label
- Icotinib of high dose
- description
- Icotinib: 375mg, oral administration, three times per day.
- interventionNames
- Drug: Icotinib of high dose
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with Histologic or cytologic confirmation. * Wild type epidermal growth factor receptor status. * Progressed after first-line chemotherapy. * No previous systemic anticancer therapy. * Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated. * Provision of written informed consent. Exclusion Criteria: * Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). * Positive epidermal growth factor receptor mutation. * Known severe hypersensitivity to icotinib or any of the excipients of this product. * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.