Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation

NCT ID: NCT02044328

Last Updated: 2022-02-08

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2021-10-31

Brief Summary

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Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.

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 receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

Icotinib is administered 125 mg three times per day.

Interventions

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Icotinib

Icotinib is administered 125 mg three times per day.

Intervention Type DRUG

Other Intervention Names

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Commana BPI-2009

Eligibility Criteria

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Inclusion Criteria

* The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19 or 21 exon mutation
* The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
* The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1
* The patients signed the written informed consent

Exclusion Criteria

* Patients with unresected tumor
* Wild EGFR type
* Allergic to the study drug
* Patients have severe non-cancerous diseases
* Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhang Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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BD-IC-IV57

Identifier Type: -

Identifier Source: org_study_id

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