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

November 10, 2016 updated by: Shengyu Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • 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
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 10 months
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 24 months
24 months
tumor response rate
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

November 6, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMS-ZH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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