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

Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Icotinib

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib; Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.	Drug: Icotinib; Icotinib is administered 125 mg three times per day.; Other Names: Commana; BPI-2009

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year Survival Rates		1 year
3-year Survival Rates		3 years
Number of patients suffered adverse events	Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0	42 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of disease-free survival by status of Bcl-2 interacting mediator of cell death	Compare the disease-free survival between patients with positive Bcl-2 interacting mediator of cell death mutation and patients without this mutation.	2 years

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Zhang Yi, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

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-IV57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No