Back to resultsSequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Primary Purpose
EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sequential and maintenance icotinib
Maintenance icotinib
Sponsored by
About this trial
This is an interventional treatment trial for EGFR Positive Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Stage IV or IIIB advanced non-small cell lung cancer patients
- Positive EGFR Mutation
- Non-progressive disease after first-line gemcitabine/cisplatin therapy
- Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Exclusion Criteria:
- Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
- Patients with wild-type EGFR
- Evidence of interstitial lung diseases
- Severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Sites / Locations
- First Affiliated Hospital of Guangxi Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sequential and maintenance icotinib
Maintenance icotinib
Arm Description
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment 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.
Disease control rate (DCR)
Disease control rate including complete response (CR) o，partial response (PR) , stable disease (SD)
Full Information
NCT ID
NCT02194556
First Posted
July 16, 2014
Last Updated
July 17, 2014
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02194556
Brief Title
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Official Title
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 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, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer 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
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sequential and maintenance icotinib
Arm Type
Experimental
Arm Description
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Arm Title
Maintenance icotinib
Arm Type
Active Comparator
Arm Description
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Sequential and maintenance icotinib
Other Intervention Name(s)
Gemzar, DDP, Comana, BPI-2009
Intervention Description
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Maintenance icotinib
Other Intervention Name(s)
Gemzar, DDP, Comana, BPI-2009
Intervention Description
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg 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
24 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
Title
Disease control rate (DCR)
Description
Disease control rate including complete response (CR) o，partial response (PR) , stable disease (SD)
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:
Stage IV or IIIB advanced non-small cell lung cancer patients
Positive EGFR Mutation
Non-progressive disease after first-line gemcitabine/cisplatin therapy
Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Exclusion Criteria:
Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
Patients with wild-type EGFR
Evidence of interstitial lung diseases
Severe hypersensitivity to icotinib or any of the excipients of this product.
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohua Hu, MD
Organizational Affiliation
First Affiliated Hospital of Guangxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
NanNing
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
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