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Trial record 1 of 1 for:    D5160L00032
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Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients (RADIANCE)

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ClinicalTrials.gov Identifier: NCT03137264
Recruitment Status : Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

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).


Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: Other

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
T790M positive
Patients determined to be T790M positive on cobas tissue and/or cobas plasma testing during Part 1 may be followed for clinical outcomes in Part 2, and will be treated in accordance with standard of care, which may include osimertinib.
Drug: Other
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.
Other Name: Standard of Care

T790M negative
Patients determined to be T790M negative during Part 1 will not be followed for clinical outcomes in Part 2.



Primary Outcome Measures :
  1. The percentage of patients whose T790M results on Trovera urine AND Guardant360 plasma testing match their T790M results on cobas tissue testing. [ Time Frame: Visit 1 (Day-21 to Day 0) ]
    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.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Every 12 weeks for 12 months ]
    The number of patients achieving a confirmed partial response or complete response per RECIST 1.1 from treatment with osimertinib.

  2. Duration of Response (DoR) [ Time Frame: Every 12 weeks for the first 12 months, then at week 72 ]
    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.

  3. Progression Free Survival (PFS) [ Time Frame: Every 12 weeks for the first 12 months, then at Week 72 ]
    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.


Other Outcome Measures:
  1. Number of procedure-related adverse events and Serious Adverse Events (SAEs) [ Time Frame: Up to 8 weeks after Visit 1 ]
    To evaluate safety and tolerability of study procedures.

  2. Percentage of patients whose Trovera urine OR Guardant360 plasma T790M results are the same as their cobas tissue T790M results. [ Time Frame: Visit 1 (Day -21 to Day 0) ]
    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.

  3. 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 Frame: Visit 1 (Day -21 to Day 0) ]
    Biomarker results will be assessed and may be compared to T790M status and/or clinical response.

  4. Percentage of patients whose Trovera urine OR Guardant360 plasma EGFR mutation results are the same as their cobas tissue EGFR mutation results. [ Time Frame: Visit 1 (Day -21 to Day 0) ]
    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.

  5. Physical Exam [ Time Frame: Up to 8 weeks after Visit 1 ]
    Changes in physical exams from baseline

  6. Vital signs [ Time Frame: Up to 8 weeks after Visit 1 ]
    Changes in vital signs from baseline

  7. ECG [ Time Frame: Up to 8 weeks after Visit 1 ]
    Changes in ECGs from baseline.

  8. Number of Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest [ Time Frame: 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. ]
    To evaluate the safety and tolerability of osimertinib.

  9. Physical Exam [ Time Frame: From the time of first dose of osimertinib through the date of last dose of osimertinib or at Week 72, whichever comes first. ]
    To evaluate the safety and tolerability of osimertinib.

  10. Vital signs [ Time Frame: From the time of first dose of osimertinib through the date of last dose of osimertinib or at Week 72, whichever comes first. ]
    To evaluate the safety and tolerability of osimertinib

  11. ECG [ Time Frame: From the time of first dose of osimertinib through the date of last dose of osimertinib or at Week 72, whichever comes first. ]
    To evaluate the safety and tolerability of osimertinib


Biospecimen Retention:   Samples With DNA
Whole blood, urine, and tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population for this trial is non-small cell lung cancer patients who will come primarily from the community oncology practice setting.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137264


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Sponsors and Collaborators
AstraZeneca
Medpace, Inc.
Investigators
Study Director: Nabil Chehab, PhD AstraZeneca

Additional Information:
Publications:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03137264     History of Changes
Other Study ID Numbers: D5160L00032
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AstraZeneca:
T790M mutation
EGFR epidermal growth factor receptor
non-invasive testing
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms