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Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy 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
Pemetrexed
Carboplatin
Thoracic radiotherapy(TRT)
Sponsored by
People's Hospital of Guangxi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Inoperable stage III non-small cell lung cancer, EGFR mutation, Icotinib, Radiotherapy, Chemoradiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
  2. No previous systemic anticancer therapy.
  3. life expectancy more than three months.
  4. ECOG Performance Status of 0 to 1.
  5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  6. Patients will be required to provide informed consent before enrollment.

Exclusion Criteria:

  1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
  2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
  3. Severe heart disease, uncontrolled diabetes mellitus, or active infection.
  4. Active concomitant malignancy, and pregnancy or breast-feeding.

Sites / Locations

  • The people's Hospital of the Guangxi Zhuang Autonomous RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Icotinib with concurrent radiotherapy

Chemoradiotherapy

Arm Description

Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity.

Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity .

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.

Secondary Outcome Measures

Overall survival(OS)
Overall survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Adverse events
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Objective response rate
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Quality of life
Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.

Full Information

First Posted
March 25, 2015
Last Updated
March 30, 2015
Sponsor
People's Hospital of Guangxi
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1. Study Identification

Unique Protocol Identification Number
NCT02407366
Brief Title
Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer
Official Title
A Phase 2 Study of Icotinib With Concurrent Radiotherapy vs. Pemetrexed+ Carboplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor ( EGFR) Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
People's Hospital of Guangxi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR 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
Keywords
Inoperable stage III non-small cell lung cancer, EGFR mutation, Icotinib, Radiotherapy, Chemoradiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Icotinib with concurrent radiotherapy
Arm Type
Experimental
Arm Description
Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity.
Arm Title
Chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity .
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
BPI-2009, Conmana
Intervention Description
Icotinib (125 mg ,Three times daily)
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta, LY231514, MTA, Multitargeted Antifolate, NSC-698037
Intervention Description
Pemetrexed(500mg/m2)every 21 days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin (AUC，5) every 21 days
Intervention Type
Radiation
Intervention Name(s)
Thoracic radiotherapy(TRT)
Intervention Description
TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
Overall survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Time Frame
two years
Title
Adverse events
Description
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Time Frame
two years
Title
Objective response rate
Description
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time Frame
two years
Title
Quality of life
Description
Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.
Time Frame
two years

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. life expectancy more than three months. ECOG Performance Status of 0 to 1. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. Patients will be required to provide informed consent before enrollment. Exclusion Criteria: Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway. Severe heart disease, uncontrolled diabetes mellitus, or active infection. Active concomitant malignancy, and pregnancy or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xia Wu, intern
Phone
+86-185-789-52759
Email
353992578@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
XiangLi Lai, intern
Phone
+86-138-7719-7891
Email
249261276@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GuoSheng Feng, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuan Liang, MD
Organizational Affiliation
Guangxi Department of Public Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lin Hui, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HeMing Lu, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ChangJie Huang, MD
Organizational Affiliation
Nanning Second People's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
GuiSheng LI, MD
Organizational Affiliation
Liuzhou Workers Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HaiXin Huang, MD
Organizational Affiliation
Liuzhou Workers Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HaoLin Yan, MD
Organizational Affiliation
First People's Hospital of Yulin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ping Liang, MD
Organizational Affiliation
Guangxi Ruikang Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
BingQiang Ni, MD
Organizational Affiliation
The People's hospital of LiuZhou
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
YanRong Hao, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
XianBin Yuan, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shan Gao, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xia Wu, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
XiangLi Lai, MD
Organizational Affiliation
The People's hospital of Guangxi Zhuang Autonomous
Official's Role
Study Chair
Facility Information:
Facility Name
The people's Hospital of the Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GuoSheng Feng, professor
Phone
+86-771-218-6508
Email
fengguosheng88988@163.com

12. IPD Sharing Statement

Learn more about this trial

Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

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