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A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT01667562

Last Updated: 2019-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-20

Study Completion Date

2017-09-07

Brief Summary

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This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erlotinib

Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Daily oral doses administered until disease progression or unacceptable toxicity or death.

Diagnostic Phase

Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erlotinib

Daily oral doses administered until disease progression or unacceptable toxicity or death.

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
* Measurable disease according to RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Adequate hematological, liver and renal function
* Participants with asymptomatic and stable cerebral metastases receiving medical treatment

Exclusion Criteria

* Previous chemotherapy or treatment against EGFR for metastatic disease
* Treatment with an investigational agent less than 3 weeks before enrollment
* History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
* Participants with symptomatic cerebral metastases
* Any significant ophthalmologic abnormality
* Unstable systemic disease
* Coumarins use
* Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
* Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
* Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
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_DIRECTOR

Hoffmann-La Roche

Locations

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Clinic for Pulmonology, Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Clinical Center Bezanijska Kosa; Oncology

Belgrade, , Serbia

Site Status

Institute for pulmonary diseases of Vojvodina

Kamenitz, , Serbia

Site Status

Clinical Center Nis; Clinic for pulmonary diseases Knez Selo

Niš, , Serbia

Site Status

Countries

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Serbia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ML27860

Identifier Type: -

Identifier Source: org_study_id