Description:
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.
Title
- Brief Title: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
- Official Title: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study
Clinical Trial IDs
- ORG STUDY ID:
AKTN-NSCLC-01
- NCT ID:
NCT02404675
Conditions
Interventions
Drug | Synonyms | Arms |
---|
icotinib | conmana | 19 icotinib (125mg) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
21 icotinib (250mg) | Experimental | 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. | |
21 icotinib (125mg) | Active Comparator | 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 | |
19 icotinib (125mg) | Experimental | Patients with EGFR del 19 exon positive are 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 | |
Eligibility Criteria
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
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | 20 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rates |
Time Frame: | 12 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Betta Pharmaceuticals Co., Ltd. |
Last Updated
July 28, 2017