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

November 5, 2019 updated by: Geoffrey Oxnard, MD, Dana-Farber Cancer Institute

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Erlotinib
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turnaround Time
Time Frame: Maximum 38 days
The turnaround time from study registration to treatment initiation was recorded for the plasma genotyping strategy versus standard tumor genotyping. For rapid plasma genotyping, turnaround time is the time between ordering plasma genotyping and obtaining results; this time period was compared to the turnaround time of obtaining the tumor genotyping results.
Maximum 38 days
Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping
Time Frame: PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.
Concordance between results of plasma genotyping and tumor genotyping, among patients with tissue available for standard genotyping
PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Geoffrey R Oxnard, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

April 16, 2019

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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