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

Adenocarcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02125240
• Other study ID #: BD-IC-IV-59
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: July 2021

Study information

• Verified date: July 2018
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Yuan-Kai Shi, MD
• Phone: 010-87788293
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: July 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• EGFR Positive Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib
125 mg three times daily (375 mg per day) by mouth
• Placebo
1 tablet three times daily by mouth

Locations

Country	Name	City	State
China	304 Hospital of PLA	Beijing	Beijing
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Union Medical College Hospital	Beijing	Beijing
China	Cancer Hospital, Chinese Academy of Medical Science	Beijing	Beijing
China	Capital Medical University, Beijing Chest Hospital	Beijing	Beijing
China	China-japan friendship hospital in Beijing	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	People's Liberation Army General Hospital (301 Hospital)	Beijing	Beijing
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
Primary	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	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
Secondary	Lung cancer symptoms and health-related quality of life (HRQoL) differences		60 months
Secondary	Number of participants with adverse events		36 months