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

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.

Study Overview

• Status: Unknown
• Conditions: Adenocarcinoma; EGFR Positive Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Icotinib; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Not yet recruiting
      • Peking University First Hospital
      • Principal Investigator: Jian Li, MD
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Principal Investigator: Jun Wang, MD
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Beijing Hospital
      • Principal Investigator: Gang Cheng, MD
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital, Chinese Academy of Medical Science
      • Principal Investigator: Yuan-Kai Shi, MD
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Chaoyang Hospital
      • Principal Investigator: Hui Li, MD
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Beijing Union Medical College Hospital
      • Principal Investigator: Li Zhang, MD
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-japan friendship hospital in Beijing
      • Principal Investigator: De-Ruo Liu, MD
    • Beijing, Beijing, China, 100048
      • Recruiting
      • 304 Hospital of PLA
      • Principal Investigator: Wen-Hua Xiao, MD
    • Beijing, Beijing, China, 100053
      • Not yet recruiting
      • Xuanwu Hospital, Capital Medical University
      • Principal Investigator: Xiu-Yi Zhi, MD
    • Beijing, Beijing, China, 100853
      • Not yet recruiting
      • People's Liberation Army General Hospital (301 Hospital)
      • Principal Investigator: Yi Hu, MD
    • Beijing, Beijing, China, 101149
      • Recruiting
      • Capital Medical University, Beijing Chest Hospital
      • Principal Investigator: Shu-Cai Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib; 125 mg three times daily (375 mg per day) by mouth	Drug: Icotinib; 125 mg three times daily (375 mg per day) by mouth; Other Names: BPI-2009; Conmana
Active Comparator: Placebo; 1 tablet three times daily by mouth	Drug: Placebo; 1 tablet three times daily by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 months
Lung cancer symptoms and health-related quality of life (HRQoL) differences		60 months
Number of participants with adverse events		36 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Yuan-Kai Shi, MD, Cancer Hospital, Chinese Academy of Medical Science

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: BD-IC-IV-59