The study is being done to determine if non-invasive testing (urine and plasma testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status. EGFR is a type of protein found on the surface of cells in the body. When this protein is mutated and becomes too active, it can lead to cancer growth. T790M is a mutation that develops in response to treatment of the EGFR mutation. Participating patients will have tumor tissue (via cobas test), as well as 2 plasma samples (via cobas and Guardant360 tests) and 1 urine sample (via Trovera test), tested for EGFR T790M mutation status. If the results of the cobas tissue and/or plasma test show that a patient is T790M positive, they will be treated according to standard of care, which may include treatment with osimertinib. Osimertinib is approved for use in the United States for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC).
Name: Other
Description: Patients who are T790M positive via cobas plasma and/or cobas tissue testing during Part 1 will be treated per standard of care during Part 2, which may include osimertinib.Type: DrugT790M positive
Description: The Overall Percent Agreement will be estimated as analytic concordance between Guardant360 plasma and Trovera urine testing versus cobas tissue testing in identifying T790M status (positive or negative). The Positive Percent Agreement will be estimated as the percentage of cobas tissue positive patients who are also Guardant360 plasma and/or Trovera urine positive. The Negative Percent Agreement will be estimated as the percentage of cobas tissue negative patients who are also Guardant360 plasma and Trovera urine negative.
Measure: The percentage of patients whose T790M results on Trovera urine AND Guardant360 plasma testing match their T790M results on cobas tissue testing. Time: Visit 1 (Day-21 to Day 0)Description: The number of patients achieving a confirmed partial response or complete response per RECIST 1.1 from treatment with osimertinib.
Measure: Objective Response Rate (ORR) Time: Every 12 weeks for 12 monthsDescription: The time from first documented tumor response defined by RECIST 1.1 from osimertinib treatment until the date of documented progression or death from any cause.
Measure: Duration of Response (DoR) Time: Every 12 weeks for the first 12 months, then at week 72Description: Defined as the time from date of first dose of osimertinib until the date of disease progression by RECIST 1.1 or death by any cause.
Measure: Progression Free Survival (PFS) Time: Every 12 weeks for the first 12 months, then at Week 72Description: To evaluate safety and tolerability of study procedures.
Measure: Number of procedure-related adverse events and Serious Adverse Events (SAEs) Time: Up to 8 weeks after Visit 1Description: The overall percent agreement will be estimate as analytic concordance between cobas tissue and Guardant360 plasma, and cobas tissue and Trovera urine testing in identifying T790M status. The positive percent agreement will be estimated as the percentage of cobas tissue positive patients who are also Guardant360 plasma positive and cobas tissue positive patients who are Trovera urine positive. The negative percent agreement will be estimated as the percentage of cobas tissue negative patients who are also Guardant360 plasma negative and cobas tissue negative patients who are Trovera urine negative.
Measure: Percentage of patients whose Trovera urine OR Guardant360 plasma T790M results are the same as their cobas tissue T790M results. Time: Visit 1 (Day -21 to Day 0)Description: Biomarker results will be assessed and may be compared to T790M status and/or clinical response.
Measure: The presence of additional biomarkers from the blood and/or urine of NSCLC patients who have progressed during or following treatment with an EGFR tyrosine kinase inhibitor Time: Visit 1 (Day -21 to Day 0)Description: The overall percent agreement will be estimated as analytic concordance between Guardany360 plasma and Trovera urine testing versus cobas tissue testing in identifying the status of specified EGFR mutations. The positive percent agreement will be estimated as the percentage of cobas tissue positive patients who are also Guardant360 plasma and/or Trovera urine positive. The negative percent agreement will be estimated as the percentage of cobas tissue negative patients who are also Guardant360 plasma and Trovera urine negative.
Measure: Percentage of patients whose Trovera urine OR Guardant360 plasma EGFR mutation results are the same as their cobas tissue EGFR mutation results. Time: Visit 1 (Day -21 to Day 0)Description: Changes in physical exams from baseline
Measure: Physical Exam Time: Up to 8 weeks after Visit 1Description: Changes in vital signs from baseline
Measure: Vital signs Time: Up to 8 weeks after Visit 1Description: Changes in ECGs from baseline.
Measure: ECG Time: Up to 8 weeks after Visit 1Description: To evaluate the safety and tolerability of osimertinib.
Measure: Number of Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest Time: From the time of first dose of osimertinib through 30 days past the last dose of osimertinib or 30 days after Week 72, if osimertinib treatment remains ongoing at Week 72.Description: To evaluate the safety and tolerability of osimertinib.
Measure: Physical Exam Time: From the time of first dose of osimertinib through the date of last dose of osimertinib or at Week 72, whichever comes first.Description: To evaluate the safety and tolerability of osimertinib
Measure: Vital signs Time: From the time of first dose of osimertinib through the date of last dose of osimertinib or at Week 72, whichever comes first.Description: To evaluate the safety and tolerability of osimertinib
Measure: ECG Time: From the time of first dose of osimertinib through the date of last dose of osimertinib or at Week 72, whichever comes first.Cohort
There is one SNP
An Open-Label, Non-randomized, Prospective Biomarker Study to Assess Analytic Concordance Between Non-invasive Testing and Tissue Testing for EGFR T790M Mutation Detection in Patients With Non-small Cell Lung Cancer. --- T790M ---
Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients The study is being done to determine if non-invasive testing (urine and plasma testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status. --- T790M ---
T790M is a mutation that develops in response to treatment of the EGFR mutation. --- T790M ---
Participating patients will have tumor tissue (via cobas test), as well as 2 plasma samples (via cobas and Guardant360 tests) and 1 urine sample (via Trovera test), tested for EGFR T790M mutation status. --- T790M ---
If the results of the cobas tissue and/or plasma test show that a patient is T790M positive, they will be treated according to standard of care, which may include treatment with osimertinib. --- T790M ---
Osimertinib is approved for use in the United States for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). --- T790M ---
The percentage of patients whose T790M results on Trovera urine AND Guardant360 plasma testing match their T790M results on cobas tissue testing.. --- T790M ---
The percentage of patients whose T790M results on Trovera urine AND Guardant360 plasma testing match their T790M results on cobas tissue testing.. --- T790M --- --- T790M ---
The Overall Percent Agreement will be estimated as analytic concordance between Guardant360 plasma and Trovera urine testing versus cobas tissue testing in identifying T790M status (positive or negative). --- T790M ---
To evaluate safety and tolerability of study procedures.. Percentage of patients whose Trovera urine OR Guardant360 plasma T790M results are the same as their cobas tissue T790M results.. --- T790M ---
To evaluate safety and tolerability of study procedures.. Percentage of patients whose Trovera urine OR Guardant360 plasma T790M results are the same as their cobas tissue T790M results.. --- T790M --- --- T790M ---
The overall percent agreement will be estimate as analytic concordance between cobas tissue and Guardant360 plasma, and cobas tissue and Trovera urine testing in identifying T790M status. --- T790M ---
Biomarker results will be assessed and may be compared to T790M status and/or clinical response.. Percentage of patients whose Trovera urine OR Guardant360 plasma EGFR mutation results are the same as their cobas tissue EGFR mutation results.. --- T790M ---
Inclusion Criteria: - Provision of informed consent prior to any study-specific procedures - Females and males >/= 18 years - Primary diagnosis of NSCLC with evidence of disease progression during or following treatment with an EGFR tyrosine kinase inhibitor (diagnosis of NSCLC that is confirmed by cytology is acceptable) - Willing to undergo tumor biopsy (e.g., excision, core biopsy, or endoscopic biopsy), preferably of a progressing lesion, and provide blood and urine for biomarker testing - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Involvement in the planning and/or conduct of the study - Prior treatment with osimertinib or another T790M directed therapy - Current participation in another clinical study with an investigational product or patients who plan to receive any treatment that is not FDA-approved for EGFR mutation positive NSCLC at any time during the course of this study - Use of any chemotherapeutic agent within 1 week of tissue, plasma, and urine sample collection - For women - currently pregnant or plan to become pregnant during the course of the study: pre-menopausal women of childbearing potential must have a urine or serum pregnancy test performed during the screening/enrollment period and prior to initiating anti-cancer treatment - Judgment by the investigator that the patient should not participate in the study due to the patient being unlikely to comply with study procedures, restrictions, and requirements, such as in the case of severe or uncontrolled systemic disease. --- T790M ---
Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung RADIANCE is an open-label, prospective biomarker study to assess analytic concordance between non-invasive testing (plasma and urine) and tissue testing for the EGFR T790M mutation. --- T790M ---
All patients will have tumor tissue (via cobas test) as well as 2 plasma samples (via cobas and Guardant360) and 1 urine sample (via Trovera) tested for the EGFR T790M mutation (Part 1). --- T790M ---
Patients who are confirmed T790M negative based on both cobas biomarker tests (tissue and plasma) will have completed the study. --- T790M ---