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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02961270

Enrollment

Registered

2016-11-10

Start date

2016-11-30

Completion date

2018-08-31

Last updated

2016-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

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

Interventions

DRUGIcotinib

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
progression-free survival	10 months

Secondary

Measure	Time frame
tumor response rate	2 months
overall survival	24 months

Countries

China

Contacts

Primary ContactShenyu Zhou, MD

typhoonwho@126.com86 13520852899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026