Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation

Non-small Cell Lung Cancer Clinical Trial

Official title:

Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02961270
• Other study ID #: CAMS-ZH-001
• Status: Recruiting
• Phase: Phase 2
• First received: November 6, 2016
• Last updated: November 10, 2016
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Shenyu Zhou, MD
• Phone: 86 13520852899
• Email: typhoonwho[@]126.com
• Is FDA regulated: No
• Health authority: China: National health and family planning commission of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with stage IIIB/IV non-small cell lung cancer

• Patients with uncommon epidermal growth factor receptor (EGFR) mutation

• Targeted-therapy-naive patients

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

• Evaluable target lesions according to RECIST 1.1 for tumour response assessment

Exclusion Criteria:

• Wild-type EGFR

• Positive 19 del and/or 21 L858R mutation

• Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib

• Patients who have documented history of interstitial lung disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib
Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity

Locations

Country	Name	City	State
China	Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		10 months	No
Secondary	tumor response rate		2 months	No
Secondary	overall survival		24 months	No