High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
INCREASE
1 other identifier
interventional
240
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJuly 28, 2017
July 1, 2017
2.7 years
March 26, 2015
July 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
12 months
Secondary Outcomes (2)
Overall survival
20 months
Objective response rates
12 weeks
Study Arms (3)
21 icotinib (250mg)
EXPERIMENTALPatients 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 COMPARATORPatients 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)
EXPERIMENTALPatients 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Chest Hospital, Capital Medical University
Beijing, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
March 31, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2017
Study Completion
September 1, 2018
Last Updated
July 28, 2017
Record last verified: 2017-07