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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02770014
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : January 7, 2019
Astellas Pharma Inc
Information provided by (Responsible Party):
Geoffrey Oxnard, MD, Dana-Farber Cancer Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer Drug: Erlotinib Phase 2

Detailed Description:

This research study is a Phase II clinical trial. This research study will determine if a rapid blood test can be used to detect EGFR mutations in patients with newly diagnosed lung cancer and use that information to rapidly start patients on a pill-based therapy.

This blood test has not previously been used to select patients for treatment with Erlotinib without confirming this finding on a biopsy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer
Study Start Date : June 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: EGFR Exon 19 Positive Treatment With Erlotinib
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
Drug: Erlotinib
Other Name: Tarceva

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. - Determine The Time From Study Registration To Treatment Initiation Using A Rapid Plasma Genotyping Strategy Versus Standard Tumor Genotyping. [ Time Frame: 2 years ]
  2. - Ascertain The Positive Predictive Value And False Negative Rate Of Plasma Genotyping For Patients With Recently Diagnosed Advanced NSCLC Among Patients With Tissue Available For Standard Genotyping [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic NSCLC including recurrent disease
  • EGFR genotype must not be known. However, pending EGFR tumor genotyping is allowed.

    --Participants with positive or pending EGFR mutation on plasma genotyping performed at the central lab are eligible for enrollment, and will not need to repeat initial plasma genotyping on study.

  • Tissue must be available for genotyping or biopsy planned to obtain tissue for genotyping. Biopsy requirement may be waived if not technically feasible and plasma genotyping reveals an eligible EGFR mutation (exon 19 del/L858R). Determination of technical feasibility must be made independently of plasma genotyping results.
  • Participants must possess at least two of the following clinical characteristics which enrich for EGFR mutations:

    • smoked less than 10 pack years
    • Asian race.
    • Adenocarcinoma (including adenosquamous carcinoma) on histology or cytology.
  • Participants must have measurable disease with at least one lesion that can be accurately measured in longest dimension as >2 cm with conventional imaging techniques or >1 cm with a spiral CT scan per RECIST v1.1.
  • Participants must have progressive, advanced cancer as defined by one of the following:

    • Newly diagnosed, untreated advanced disease
    • Newly diagnosed, untreated metastatic recurrence of earlier stage disease (previous treatment of early stage disease allowed).
    • Clinical determination of progressive disease on previous systemic therapy as evidenced by plan to change treatment. Any number of prior therapies are acceptable excluding previous EGFR kinase inhibitors.
  • Age 18 years or older.
  • ECOG performance status 0-2.
  • Participant must be able to understand and give consent to participate in the study.
  • Patient must be a candidate for systemic therapy with erlotinib based on clinical assessment. Patients must meet the following criteria before beginning therapy (Note: these are not required for initial study enrollment and plasma genotyping):

    • ECOG performance status of 0-2
    • Platelets >75
    • AST & ALT < 3x the upper limit of normal
    • Creatinine clearance > 30 mL/min by Cockroft-Gault
    • No other contraindication to erlotinib
    • Female participants of child-bearing age must agree to use adequate contraception (hormonal, barrier or abstinence) for the duration of the study while receiving erlotinib and undergo a pregnancy test. Any evidence or suspicion of pregnancy should be reported to the treating physician immediately.
    • Male participants must agree to use adequate contraception for the duration of the study while receiving erlotinib

Exclusion Criteria:

  • Participants must not have had chemotherapy within the past 10 days.
  • Participants must not have had prior treatment with an EGFR kinase inhibitor, EGFR directed therapy or investigational agent.
  • Participants must not have residual adverse events from previous therapy greater than CTCAE v4.0 grade 2 at the time of registration.
  • Participants must not have symptomatic brain metastases or brain metastases requiring steroids. Asymptomatic brain metastases not requiring steroids are acceptable.
  • Participant must not have a history of allergy to erlotinib.
  • Second primary cancer which is active and requiring treatment.
  • Participants must not be pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02770014

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Astellas Pharma Inc
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Principal Investigator: Geoffrey R Oxnard, MD Dana-Farber Cancer Institute

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Responsible Party: Geoffrey Oxnard, MD, Dana-Farber Cancer Institute Identifier: NCT02770014     History of Changes
Other Study ID Numbers: 16-093
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Geoffrey Oxnard, MD, Dana-Farber Cancer Institute:
Non-Small Cell Lung Cancer
Epidermal Growth Factor Receptor

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action