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

NCT02770014 | Terminated Phase 2 Results DMC

• 1 other identifier: 16-093
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Epidermal Growth Factor Receptor; Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Epidermal Growth Factor Receptor

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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 Outcomes (2)

• Turnaround Time

  Maximum 38 days

• Positive Predictive Value (PPV) And False Negative Rate Of Plasma 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.

Study Arms (1)

EGFR mutation Positive, Treatment With Erlotinib

EXPERIMENTAL

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

Interventions

Erlotinib DRUG

Also known as: Tarceva

EGFR mutation Positive, Treatment With Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Astellas Pharma Inc: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Geoffrey Oxnard, MD
• Organization: Dana-Farber Cancer Institute

geoffrey_oxnard@dfci.harvard.edu

617-632-6049

Study Officials

• Geoffrey R Oxnard, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Geoffrey Oxnard, MD

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: June 1, 2016
• Primary Completion: April 16, 2019
• Study Completion: June 19, 2019
• Last Updated: November 22, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)