Clinical trial · Interventional
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study
NCT02404675CI-TRIAL-00028836INCREASEunknownPhase 4ClinicalTrials.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 randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.
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 |
|---|---|---|---|
| NSCLC | 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 (3)
- type
- EXPERIMENTAL
- label
- 21 icotinib (250mg)
- description
- Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity.
- interventionNames
- Drug: icotinib
- type
- ACTIVE_COMPARATOR
- label
- 21 icotinib (125mg)
- description
- Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
- interventionNames
- Drug: icotinib
- type
- EXPERIMENTAL
- label
- 19 icotinib (125mg)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology) * Positive EGFR 21 exon mutation or 19 exon deletion * Age 18-75 years old with performance status of 0 to 2 * With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria * Adequate hematological, biochemical and organ functions. Exclusion Criteria: * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases. * Evidence of interstitial lung diseases * 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.