Rapid Blood Test in Detecting EGFR Mutation for Early Initiation of Erlotinib Hydrochloride in Treating Patients with Advanced Lung Cancer

Inclusion Criteria

• CRITERIA FOR PLASMA GENOTYPING
• 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 computed tomography (CT) scan per Response Evaluation Criteria in Solid Tumors version 1.1 (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
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Participant must be able to understand and give consent to participate in the study
• CRITERIA FOR SYSTEMIC THERAPY WITH ERLOTINIB
• 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 * Aspartate aminotransferase (AST) & alanine aminotransferase (ALT) < 3 x 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 Common Terminology Criteria for Adverse Events version 4.0 (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 known to be pregnant or breastfeeding