NCT02103257|UnknownPhase 4DMC
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Sponsor study identifier
interventional
192
1 country
31
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 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.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 31, 2014
Actual (reported)April 3, 2014
Actual (reported)March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 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
15 months
Adverse events
24 months
Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Lanzhou military region general hospital
Lanzhou, Gansu, 730050, China
General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010, China
Cancer Hospital of Sun Yat-sen
Guangzhou, Guangdong, 510060, China
Helong Zhang, MD
Tang-Du Hospital
First Submitted
March 31, 2014
First Posted
April 3, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
Icotinib 125 mg is administered orally 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.
Contact the study team to confirm eligibility.
First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120, China
Jiangmen central hospital
Jiangmen, Guangdong, 529030, China
The university of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Medical Oncology,Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Thoracic Surgery,Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Guangdong Agribusiness Center Hospital
Zhanjiang, Guangdong, 524009, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Hainan Provincal Nong Ken Hospital
Haikou, Hainan, 570311, China
Hainan Provincial People's Hospital
Haikou, Hainan, 570311, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Medical Oncology，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Radiation Oncology，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Respiratory medicine，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Baoji Central Hospital
Baoji, Shanxi, 721008, China
3201 Hospital, Hanzhong, Shanxi
Hanzhong, Shanxi, 723000, China
Shaanxi province people's hospital
Xi’an, Shanxi, 710000, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
Xi'an Chang'an Hospital
Xi’an, Shanxi, 710018, China
Tangdu Hospital，Fourth Military Medical University
Xi’an, Shanxi, 710038, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Shanxi Cancer Hospital
Xi’an, Shanxi, 710061, China
Urumqi General Hospital of Lanzhou Military Region General Hospital
Ürümqi, Xinjiang, 830000, China
Xinjiang medical university affiliated tumor hospital
Ürümqi, Xinjiang, 830000, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Autonome Region Xinjiang Uygur Chinese medicine hospital
Ürümqi, Xinjiang, 830099, China
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 29, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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