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Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer

NCT ID: NCT01498562

Last Updated: 2014-12-02

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-06-30

Brief Summary

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Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Detailed Description

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Reversible EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, were shown to be effective in patients with non-small cell lung cancer (NSCLC). However, patients almost invariably develop resistance to TKIs and have disease progression. Nimotuzumab is a humanized monoclonal antibody targeting the EGFR.

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Conditions

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Non Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gefitinib plus Nimotuzumab

Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)

Group Type EXPERIMENTAL

Gefitinib and Nimotuzumab

Intervention Type DRUG

Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)

Gefitinib alone

Mono-therapy group: Gefitinib(250mg daily)

Group Type ACTIVE_COMPARATOR

Gefitinib

Intervention Type DRUG

Mono-therapy group: Gefitinib(250mg daily)

Interventions

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Gefitinib and Nimotuzumab

Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)

Intervention Type DRUG

Gefitinib

Mono-therapy group: Gefitinib(250mg daily)

Intervention Type DRUG

Other Intervention Names

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h-R3 Iressa

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent prior to any study specific procedures
* Unresectable non-small cell lung cancer
* ECOG performance status of 0 to 2
* Male or female; ≥ 20 years of age
* Subjects whose disease has progressed after platinum-based chemotherapy
* Subjects with measurable lesion

Exclusion Criteria

* Inadequate organ functions
* Disease progression after 2 or more previous chemotherapy regimens
* Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab
* Any clinically significant gastrointestinal abnormalities
* Past medical history of interstitial lung disease
* Pregnant or lactating female
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital, Yonsei Cancer Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim HR, Jang JS, Sun JM, Ahn MJ, Kim DW, Jung I, Lee KH, Kim JH, Lee DH, Kim SW, Cho BC. A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01). Oncotarget. 2017 Feb 28;8(9):15943-15951. doi: 10.18632/oncotarget.13056.

Reference Type DERIVED
PMID: 27823977 (View on PubMed)

Related Links

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http://www.iseverance.com/

PI site

Other Identifiers

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4-2011-0662

Identifier Type: -

Identifier Source: org_study_id