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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Icotinib

• Registration Number: NCT02961270
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-06
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11
• Primary Completion: 2017-12
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
icotinib	Icotinib	patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity

Primary Outcome Measures

Name	Time	Method
progression-free survival	10 months

Secondary Outcome Measures

Name	Time	Method
tumor response rate	2 months
overall survival	24 months

Trial Locations

Locations (1)

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, China