Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02770014
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation) in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study. This research study is evaluating a new blood test that is capable of detecting an EGFR mutation in cancer without a biopsy.

Key Dates

First listed
May 12, 2016
Start date
Jun 30, 2016
Status verified
Nov 2019
Primary completion
Apr 16, 2019
Completion
Jun 19, 2019

Study Design

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

Arms

  • Experimental: EGFR mutation Positive, Treatment With Erlotinib
    Eligible EGFR mutations include exon 19 deletion or exon 21 L858R mutation. Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis

Primary Outcome Measure

Overall Response Rate [ Time Frame: From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-

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