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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, Cancer Institute and Hospital, 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, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description
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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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Icotinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: icotinib
patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity
 Drug: Icotinib
Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. tumor response rate [ Time Frame: 2 months ]
  2. overall survival [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961270


Contacts
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Contact: Shenyu Zhou, MD 86 13520852899 typhoonwho@126.com

Locations
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China
Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs Recruiting
Beijing, China, 100021
Contact: Shengyu Zhou, MD       typhoonwho@126.com   
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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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
More Information
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Responsible Party: Shengyu Zhou, Director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02961270    
Other Study ID Numbers: CAMS-ZH-001
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms