Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer
1 other identifier
interventional
100
1 country
1
Brief Summary
Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2014
Longer than P75 for phase_2
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
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 27, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedOctober 22, 2014
October 1, 2014
3 years
September 27, 2014
October 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years
Secondary Outcomes (1)
Number of Participants with Adverse Effects
duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years
Study Arms (1)
intercalated treatment
EXPERIMENTALPatients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing completely resection of EGRF mutation-positive NSCLC
- Staging ⅠB (with high risk factor) to ⅢA
- PS\<2
- Adequate hematological, biochemical and organ functions.
You may not qualify if:
- Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Kaican Cai, MD
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician，Associate Professor
Study Record Dates
First Submitted
September 27, 2014
First Posted
October 22, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2017
Study Completion
July 1, 2019
Last Updated
October 22, 2014
Record last verified: 2014-10