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Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation (ICAPE)

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
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 present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma 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 ≤ 0-1
  • The patients signed the written informed consent

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

  • Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib

Arm Description

Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

1-year Survival Rates
3-year Survival Rates
Number of patients suffered adverse events
Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0

Full Information

First Posted
January 21, 2014
Last Updated
January 24, 2022
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02044328
Brief Title
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation
Acronym
ICAPE
Official Title
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
October 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Commana, BPI-2009
Intervention Description
Icotinib is administered 125 mg three times per day.
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
1-year Survival Rates
Time Frame
1 year
Title
3-year Survival Rates
Time Frame
3 years
Title
Number of patients suffered adverse events
Description
Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0
Time Frame
42 months
Other Pre-specified Outcome Measures:
Title
Difference of disease-free survival by status of Bcl-2 interacting mediator of cell death
Description
Compare the disease-free survival between patients with positive Bcl-2 interacting mediator of cell death mutation and patients without this mutation.
Time Frame
2 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: The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma 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 ≤ 0-1 The patients signed the written informed consent 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Yi, MD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Learn more about this trial

Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation

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