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Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Primary Purpose

Non-small-cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
1-year treatment with icotinib
2-year treatment with icotinib
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:

  • The patients signed the written informed consent
  • The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
  • The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
  • The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion Criteria:

  • Patients with unresected tumor
  • Wild EGFR type
  • Allergic to the study drug
  • Patients have severe non-cancerous diseases
  • Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Sites / Locations

  • Beijing Cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1-year treatment with icotinib

2-year treatment with icotinib

Arm Description

Patients will receive 1-year treatment with icotinib after operation.

Patients will receive 2-year treatment with icotinib after operation.

Outcomes

Primary Outcome Measures

Recurrence-free Survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
August 21, 2013
Last Updated
May 21, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01929200
Brief Title
Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
Official Title
Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
August 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 study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.
Detailed Description
Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

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
1-year treatment with icotinib
Arm Type
Experimental
Arm Description
Patients will receive 1-year treatment with icotinib after operation.
Arm Title
2-year treatment with icotinib
Arm Type
Experimental
Arm Description
Patients will receive 2-year treatment with icotinib after operation.
Intervention Type
Drug
Intervention Name(s)
1-year treatment with icotinib
Other Intervention Name(s)
Commana, BPI-2009
Intervention Description
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
Intervention Type
Drug
Intervention Name(s)
2-year treatment with icotinib
Other Intervention Name(s)
Commana, BPI-2009
Intervention Description
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.
Primary Outcome Measure Information:
Title
Recurrence-free Survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
6 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: The patients signed the written informed consent The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2 Exclusion Criteria: Patients with unresected tumor Wild EGFR type Allergic to the study drug Patients have severe non-cancerous diseases Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Yang, MD
Phone
86-10-88196568
Email
zlyangyue@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Yang, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Yang, MD
Phone
86-10-88196568
Email
zlyangyue@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yue Yang, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23621919
Citation
Lv C, Ma Y, Feng Q, Fang F, Bai H, Zhao B, Yan S, Wu N, Zheng Q, Li S, Chen J, Wang J, Feng Y, Wang Y, Pei Y, Fang J, Yang Y. A pilot study: sequential gemcitabine/cisplatin and icotinib as induction therapy for stage IIB to IIIA non-small-cell lung adenocarcinoma. World J Surg Oncol. 2013 Apr 26;11:96. doi: 10.1186/1477-7819-11-96.
Results Reference
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Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

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