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Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma (ICWIP)

Primary Purpose

EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Icotinib
Placebo
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:

  • Pathologically confirmed lung adenocarcinoma after surgical resection
  • Stage II-IIIA disease according to 7th edition of TNM staging
  • Patients must harbor sensitive EGFR gene mutation (19/21)
  • Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

Exclusion Criteria:

  • Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
  • Presence of metastatic disease
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity from previous anticancer therapy
  • Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

Sites / Locations

  • Beijing Chaoyang HospitalRecruiting
  • Beijing HospitalRecruiting
  • Beijing Union Medical College HospitalRecruiting
  • Cancer Hospital, Chinese Academy of Medical ScienceRecruiting
  • China-japan friendship hospital in BeijingRecruiting
  • Peking University First Hospital
  • Peking University People's HospitalRecruiting
  • 304 Hospital of PLARecruiting
  • Xuanwu Hospital, Capital Medical University
  • People's Liberation Army General Hospital (301 Hospital)
  • Capital Medical University, Beijing Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Icotinib

Placebo

Arm Description

125 mg three times daily (375 mg per day) by mouth

1 tablet three times daily by mouth

Outcomes

Primary Outcome Measures

Disease-free survival
DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.

Secondary Outcome Measures

Overall survival
OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Lung cancer symptoms and health-related quality of life (HRQoL) differences
Number of participants with adverse events

Full Information

First Posted
April 24, 2014
Last Updated
July 12, 2018
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02125240
Brief Title
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
Acronym
ICWIP
Official Title
Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
July 2021 (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
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Detailed Description
This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma. Primary Outcome Measure: Disease-free survival between Icotinib group and placebo group. Secondary Outcome Measures: Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Icotinib
Arm Type
Experimental
Arm Description
125 mg three times daily (375 mg per day) by mouth
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
1 tablet three times daily by mouth
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
BPI-2009, Conmana
Intervention Description
125 mg three times daily (375 mg per day) by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet three times daily by mouth
Primary Outcome Measure Information:
Title
Disease-free survival
Description
DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Time Frame
60 months
Title
Lung cancer symptoms and health-related quality of life (HRQoL) differences
Time Frame
60 months
Title
Number of participants with adverse events
Time Frame
36 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: Pathologically confirmed lung adenocarcinoma after surgical resection Stage II-IIIA disease according to 7th edition of TNM staging Patients must harbor sensitive EGFR gene mutation (19/21) Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy Exclusion Criteria: Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc Presence of metastatic disease Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Any unresolved chronic toxicity from previous anticancer therapy Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan-Kai Shi, MD
Phone
010-87788293
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan-Kai Shi, MD
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li, MD
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Cheng, MD
Facility Name
Beijing Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD
Facility Name
Cancer Hospital, Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan-Kai Shi, MD
Facility Name
China-japan friendship hospital in Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De-Ruo Liu, MD
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Li, MD
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang, MD
Facility Name
304 Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Hua Xiao, MD
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiu-Yi Zhi, MD
Facility Name
People's Liberation Army General Hospital (301 Hospital)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Hu, MD
Facility Name
Capital Medical University, Beijing Chest Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Cai Zhang, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32606956
Citation
Liu YT, Hao XZ, Liu DR, Cheng G, Zhang SC, Xiao WH, Hu Y, Liu JF, He M, Ding CM, Zhang L, Wang J, Li H, Dong GL, Zhi XY, Li J, Shi YK. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020 Jun 17;12:4633-4643. doi: 10.2147/CMAR.S240275. eCollection 2020.
Results Reference
derived

Learn more about this trial

Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

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