Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

NCT00567359 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-12-11

Study results available
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Summary

In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.

Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.

Conditions

Interventions

DRUG

Erlotinib

Oral drug taken daily around the same time. Starting dose is 150mg once daily.

Sponsors & Collaborators

Principal Investigators

  • Lecia V. Sequist, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00567359 on ClinicalTrials.gov