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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.
Full 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.
Enrollment
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Volunteers
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:
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:
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):
Exclusion criteria
Primary purpose
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43 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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