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

NCT ID: NCT02961270

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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icotinib

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

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

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

Interventions

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Icotinib

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shengyu Zhou

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shengyu Zhou, MD

Role: STUDY_CHAIR

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs

Locations

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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

Site Status RECRUITING

Countries

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China

Central Contacts

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Shenyu Zhou, MD

Role: CONTACT

Phone: 86 13520852899

Email: [email protected]

Facility Contacts

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Shengyu Zhou, MD

Role: primary

Other Identifiers

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CAMS-ZH-001

Identifier Type: -

Identifier Source: org_study_id