NCT02194556|UnknownPhase 4DMC
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Sponsor study identifier
interventional
100
1 country
1
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 16, 2014
Actual (reported)July 18, 2014
Actual (reported)July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Progression Free Survival
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
15 months
Overall survival
24 months
Objective response rate
24 months
Adverse events
24 months
Disease control rate (DCR)
24 months
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Xiaohua Hu, MD
First Affiliated Hospital of Guangxi Medical University
First Submitted
July 16, 2014
First Posted
July 18, 2014
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 18, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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