Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer

August 11, 2014 updated by: Betta Pharmaceuticals Co., Ltd.

Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation

This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing, China, 100021
        • Chinese Academy of Medical Sciences Cancer Hospital
      • Beijing, Beijing, China, 100039
        • People's Liberation Army 307 Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Union Medical College Hospital
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Dongguan City People's Hospital
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen Cancer Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Zhuang Autonomous Region People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Cancer Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China, 450052
        • First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Provincial Tumor Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
      • Nantong, Jiangsu, China, 226361
        • Nantong Tumor Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Provincial Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130012
        • Tumor Hospital of Jilin Province
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning Provincial Tumor Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Cancer Hospital
      • Shanghai, Shanghai, China, 200030
        • Shanghai Chest Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Tumor Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan Provincial Tumor Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Cancer Hospital
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830000
        • First Affiliated Hospital of Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Tumor Hospital of Yunnan Province
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310006
        • Hangzhou First People's Hospital

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:

  • Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
  • No previous systemic anticancer therapy
  • Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
  • ECOG Performance Status of 0 to 1

Exclusion Criteria:

  • Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
  • Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
  • Known severe hypersensitivity to icotinib or any of the excipients of this product

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
Active Comparator: Chemoradiotherapy
Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily.
Drug: Chemoradiotherapy
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Other Names:
  • VP16
  • DDP
Experimental: Icotinib with concurrent radiotherapy
Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.
Drug: Icotinib with concurrent radiotherapy
Icotinib: 125 mg is administered orally three times per day.
Other Names:
  • BPI-2009
  • Icotinib
  • Comana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 36 months
36 months
Objective response rate
Time Frame: 8 weeks
8 weeks
Adverse events
Time Frame: 54 months
54 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: Lvhua Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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, 2014

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-IC-IV66

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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