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Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02961270
Recruitment Status : Unknown
Verified November 2016 by Shengyu Zhou, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 10, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Shengyu Zhou, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE November 6, 2016
First Posted Date  ICMJE November 10, 2016
Last Update Posted Date November 11, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
progression-free survival [ Time Frame: 10 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
  • tumor response rate [ Time Frame: 2 months ]
  • overall survival [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
Official Title  ICMJE Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
Brief Summary This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Drug: Icotinib
Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity
Study Arms  ICMJE Experimental: icotinib
patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity
Intervention: Drug: Icotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with stage IIIB/IV non-small cell lung cancer
  • Patients with uncommon epidermal growth factor receptor (EGFR) mutation
  • Targeted-therapy-naive patients
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Evaluable target lesions according to RECIST 1.1 for tumour response assessment

Exclusion Criteria:

  • Wild-type EGFR
  • Positive 19 del and/or 21 L858R mutation
  • Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
  • Patients who have documented history of interstitial lung disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02961270
Other Study ID Numbers  ICMJE CAMS-ZH-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shengyu Zhou, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shengyu Zhou, MD Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
PRS Account Chinese Academy of Medical Sciences
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP