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

Part of paid clinical trials in Stanford, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT00567359
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Oral drug taken daily around the same time. Starting dose is 150mg once daily.

Study Details

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.

Key Dates

First listed
Dec 4, 2007
Start date
Dec 31, 2007
Status verified
Nov 2018
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib

Primary Outcome Measure

2-year Disease-free Survival [ Time Frame: 2 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HosptialBostonMassachusetts02114-
North Shore Medical CenterPeabodyMassachusetts01960-
Washington University School of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Taussig Cancer CenterClevelandOhio44195-

Find similar trials in Stanford, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Stanford University· Stanford, CABeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hosptial· Boston, MANorth Shore Medical Center· Peabody, MAWashington University School of Medicine· St Louis, MO

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