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Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Primary Purpose

EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sequential Icotinib Plus Chemotherapy
Icotinib
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
  • Patients must have previously untreated locally advanced or metastatic NSCLC
  • EGFR activating mutation (exon 19 deletion, L858R) is required
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

  • Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
  • Patients with wild-type EGFR
  • Any other investigational agents are not permitted
  • Any evidence of interstitial lung disease

Sites / Locations

  • First Hospital of Lanzhou University
  • Lanzhou military region general hospital
  • General Hospital of Guangzhou Military Command
  • Cancer Hospital of Sun Yat-sen
  • First Affiliated Hospital of Guangzhou Medical College
  • Jiangmen central hospital
  • The university of Hong Kong-Shenzhen Hospital
  • Shenzhen People's Hospital
  • Medical Oncology,Shenzhen Second People's Hospital
  • Thoracic Surgery,Shenzhen Second People's Hospital
  • Peking University Shenzhen Hospital
  • Guangdong Agribusiness Center Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • Hainan Provincal Nong Ken Hospital
  • Hainan Provincial People's Hospital
  • First Affiliated Hospital of Zhengzhou University
  • Medical Oncology，General Hospital of Ningxia Medical University
  • Radiation Oncology，General Hospital of Ningxia Medical University
  • Respiratory medicine，General Hospital of Ningxia Medical University
  • Baoji Central Hospital
  • 3201 Hospital, Hanzhong, Shanxi
  • Shaanxi province people's hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Xi'an Chang'an Hospital
  • Tangdu Hospital，Fourth Military Medical UniversityRecruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
  • Shanxi Cancer Hospital
  • Urumqi General Hospital of Lanzhou Military Region General Hospital
  • Xinjiang medical university affiliated tumor hospital
  • First Affiliated Hospital of Xinjiang Medical University
  • Autonome Region Xinjiang Uygur Chinese medicine hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequential icotinib plus chemotherapy

Icotinib

Arm Description

Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.

Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.

Outcomes

Primary Outcome Measures

Progression Free Survival
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
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.
Objective response rate
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Adverse events
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.

Full Information

First Posted
March 31, 2014
Last Updated
April 27, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02103257
Brief Title
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma
Official Title
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
September 2017 (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, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential icotinib plus chemotherapy
Arm Type
Experimental
Arm Description
Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Arm Title
Icotinib
Arm Type
Active Comparator
Arm Description
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Sequential Icotinib Plus Chemotherapy
Other Intervention Name(s)
ALIMTA, DDP, Comana, BPI-2009
Intervention Description
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Comana, BPI-2009
Intervention Description
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Primary Outcome Measure Information:
Title
Progression Free Survival
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
15 months
Secondary Outcome Measure Information:
Title
Overall survival
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
24 months
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
15 months
Title
Adverse events
Description
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Time Frame
24 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: Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT) Patients must have previously untreated locally advanced or metastatic NSCLC EGFR activating mutation (exon 19 deletion, L858R) is required Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Exclusion Criteria: Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients with wild-type EGFR Any other investigational agents are not permitted Any evidence of interstitial lung disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helong Zhang, MD
Phone
13709202616
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helong Zhang, MD
Organizational Affiliation
Tang-Du Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Lanzhou military region general hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
General Hospital of Guangzhou Military Command
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Cancer Hospital of Sun Yat-sen
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangmen central hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The university of Hong Kong-Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Medical Oncology,Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Thoracic Surgery,Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangdong Agribusiness Center Hospital
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524009
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hainan Provincal Nong Ken Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hainan Provincial People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Medical Oncology，General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Radiation Oncology，General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Respiratory medicine，General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Baoji Central Hospital
City
Baoji
State/Province
Shanxi
ZIP/Postal Code
721008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
3201 Hospital, Hanzhong, Shanxi
City
Hanzhong
State/Province
Shanxi
ZIP/Postal Code
723000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shaanxi province people's hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xi'an Chang'an Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710018
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tangdu Hospital，Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helong Zhang, MD
Phone
13709202616
First Name & Middle Initial & Last Name & Degree
Helong Zhang, MD
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanxi Cancer Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Urumqi General Hospital of Lanzhou Military Region General Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xinjiang medical university affiliated tumor hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Autonome Region Xinjiang Uygur Chinese medicine hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830099
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

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