A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT02774278

Last Updated: 2016-08-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-06-30

Brief Summary

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This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.

Detailed Description

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Conditions

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Non-Squamous 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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Erlotinib

Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.

Interventions

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Erlotinib

Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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Inclusion Criteria

* Advanced NSCLC
* Tumor accessible for biopsy by bronchoscopy
* Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy

Exclusion Criteria

* Unstable systemic disease
* Any other malignancies in the last 5 years
* Brain metastases
* Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Brussels, , Belgium

Site Status

Sofia, , Bulgaria

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Tallinn, , Estonia

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Tartu, , Estonia

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Montpellier, , France

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Paris, , France

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Cologne, , Germany

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Großhansdorf, , Germany

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Hong Kong, , Hong Kong

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Dublin, , Ireland

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Perugia, , Italy

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Gdansk, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Singapore, , Singapore

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Weston-super-Mare, , United Kingdom

Site Status

Countries

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Belgium Bulgaria Estonia France Germany Hong Kong Ireland Italy Poland Russia Singapore Spain Taiwan United Kingdom

Other Identifiers

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2004-005096-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO18279

Identifier Type: -

Identifier Source: org_study_id

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