Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
ICWIP
Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
1 other identifier
interventional
124
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2014
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJuly 16, 2018
July 1, 2018
4.3 years
April 24, 2014
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
36 months
Secondary Outcomes (3)
Overall survival
60 months
Lung cancer symptoms and health-related quality of life (HRQoL) differences
60 months
Number of participants with adverse events
36 months
Study Arms (2)
Icotinib
EXPERIMENTAL125 mg three times daily (375 mg per day) by mouth
Placebo
ACTIVE COMPARATOR1 tablet three times daily by mouth
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Beijing Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
China-japan friendship hospital in Beijing
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
304 Hospital of PLA
Beijing, Beijing Municipality, 100048, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
People's Liberation Army General Hospital (301 Hospital)
Beijing, Beijing Municipality, 100853, China
Capital Medical University, Beijing Chest Hospital
Beijing, Beijing Municipality, 101149, China
Related Publications (1)
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.
PMID: 32606956DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan-Kai Shi, MD
Cancer Hospital Chinese Academy of Medical Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2014
First Posted
April 29, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2018
Study Completion
July 1, 2021
Last Updated
July 16, 2018
Record last verified: 2018-07