search
Back to results

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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib with concurrent radiotherapy
Chemoradiotherapy
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese Academy of Medical Sciences Cancer Hospital
  • People's Liberation Army 307 Hospital
  • Peking University Third Hospital
  • Beijing Union Medical College Hospital
  • Dongguan City People's Hospital
  • Sun Yat-sen Cancer Hospital
  • Nanfang Hospital
  • Guangxi Zhuang Autonomous Region People's Hospital
  • Cancer Hospital of Harbin Medical University
  • First Affiliated Hospital of Zhengzhou University
  • Tongji Hospital
  • Hunan Provincial Tumor Hospital
  • Jiangsu Cancer Hospital
  • Nantong Tumor Hospital
  • Jiangxi Provincial Cancer Hospital
  • Tumor Hospital of Jilin Province
  • Liaoning Provincial Tumor Hospital
  • Shanghai Chest Hospital
  • Fudan University Cancer Hospital
  • Shanxi Tumor Hospital
  • Sichuan Provincial Tumor Hospital
  • Tianjin Cancer Hospital
  • First Affiliated Hospital of Xinjiang Medical University
  • Tumor Hospital of Yunnan Province
  • Hangzhou First People's Hospital
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemoradiotherapy

Icotinib with concurrent radiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Objective response rate
Adverse events

Full Information

First Posted
August 11, 2014
Last Updated
August 11, 2014
Sponsor
Betta Pharmaceuticals Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02215356
Brief Title
Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
Official Title
Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Icotinib with concurrent radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Icotinib with concurrent radiotherapy
Other Intervention Name(s)
Icotinib, Comana, BPI-2009
Intervention Description
Icotinib: 125 mg is administered orally three times per day.
Intervention Type
Drug
Intervention Name(s)
Chemoradiotherapy
Other Intervention Name(s)
VP16, DDP
Intervention Description
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
36 months
Title
Objective response rate
Time Frame
8 weeks
Title
Adverse events
Time Frame
54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lvhua Wang, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaolong Fu, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
People's Liberation Army 307 Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Dongguan City People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523059
Country
China
Facility Name
Sun Yat-sen Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Guangxi Zhuang Autonomous Region People's Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Cancer Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Hunan Provincial Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226361
Country
China
Facility Name
Jiangxi Provincial Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Facility Name
Tumor Hospital of Jilin Province
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Liaoning Provincial Tumor Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanxi Tumor Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Facility Name
Sichuan Provincial Tumor Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Wulumuqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Tumor Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs