Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

May 21, 2015 updated by: Betta Pharmaceuticals Co., Ltd.

Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yue Yang, MD

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients signed the written informed consent
  • The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
  • The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
  • The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion Criteria:

  • Patients with unresected tumor
  • Wild EGFR type
  • Allergic to the study drug
  • Patients have severe non-cancerous diseases
  • Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1-year treatment with icotinib
Patients will receive 1-year treatment with icotinib after operation.
Drug: 1-year treatment with icotinib
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
Other Names:
  • Commana
  • BPI-2009
Experimental: 2-year treatment with icotinib
Patients will receive 2-year treatment with icotinib after operation.
Drug: 2-year treatment with icotinib
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.
Other Names:
  • Commana
  • BPI-2009

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free Survival
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Betta Pharmaceuticals Co., Ltd.

Investigators

  • Principal Investigator: Yue Yang, MD, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-IC-IV50

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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