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

Non-small Cell Lung Cancer Clinical Trial

— ICAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044328
• Other study ID #: BD-IC-IV57
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: October 2021

Study information

• Verified date: January 2022
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2021
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib
Icotinib is administered 125 mg three times per day.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Disease-free survival		2 years
Secondary	1-year Survival Rates		1 year
Secondary	3-year Survival Rates		3 years
Secondary	Number of patients suffered adverse events	Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0	42 months