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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Icotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02961270

CAMS-ZH-001

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

icotinib

Experimental group

Description:

patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity

Treatment:

Drug: Icotinib