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Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02762877
Recruitment Status : Terminated (Business decision)
First Posted : May 5, 2016
Results First Posted : November 25, 2019
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Genomic Health®, Inc.

Brief Summary:
A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)

Condition or disease
Non Small Cell Lung Carcinoma

Detailed Description:
This is a prospective clinical study to characterize the concordance of key clinically relevant genomic alterations in tumor tissue (biopsy/excision/cytology) and liquid biopsy (blood) using the Genomic Health LBMP in patients with stage IV non squamous NSCLC, that are either newly diagnosed with metastatic disease or progressing on therapy (any line). Tissue biopsy and blood collection (liquid biopsy) should be less than eight weeks apart and with no new systemic antitumoral treatment given in the interval between the tissue biopsy and blood collection. Local assessment of tumor tissue samples will be performed at each participating institution as per their clinical standard of care practices and results from the local assessment of genomic alteration status will be used.

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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Study to Determine the Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma From Patients With Non Small Cell Lung Carcinoma (NSCLC)
Study Start Date : April 2016
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
A
Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib)
B
Patients with non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib



Primary Outcome Measures :
  1. Concordance of Genomic Alterations in EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment [ Time Frame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks ]
    Assess concordance of genomic alterations in EGFR detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne, or locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.


Secondary Outcome Measures :
  1. Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue. [ Time Frame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks ]
    Assess concordance of genomic alterations in ALK (EML4-ALK fusions) detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne OR locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.

  2. Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib). [ Time Frame: Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy) ]
    Detection of EGFR T790M alterations in plasma using the OncotypeSEQ Liquid Select assay. Progression on EGFR targeting therapy (erlotinib, gefitinib, afatinib) assessed clinically or radiologically


Biospecimen Retention:   Samples With DNA
Blood and tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non small cell lung cancer patients
Criteria

Inclusion Criteria:

  • Subjects must be 18 years or older.
  • Patients with stage IV non squamous NSCLC who are either newly diagnosed or progressing on any treatment (progression defined as increasing tumor size or new metastatic lesions on clinical or imaging assessment).
  • Patients with available tissue sample from a metastatic site or, if the patient presents with stage IV disease at diagnosis, from the primary tumor or a metastatic site. If a patient is progressing on EGFR targeted therapy (erlotinib, gefitinib, afatinib), tumor tissue sample is required only if available.
  • No new systemic anti-tumor therapy administered in the interval between the tissue biopsy and collection of the blood sample. (interval not to exceed eight weeks). Local radiation therapy is permitted.
  • Able and willing to read, understand and sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, or equivalent privacy law, where this is applicable.

Exclusion Criteria:

  • Patients who are currently receiving therapy (targeted, immune- or chemotherapy) without sign of progression.
  • Patients with squamous NSCLC.
  • Patients with more than 8 weeks between collection of tumor specimen and collection of blood sample for analysis. (Not applicable for patients progressing on EGFR targeted therapy with no biopsy at progression)
  • Patients changing EGFR therapy due to toxicity or preference without documented disease progression.
  • Patients progressing on Osimertinib treatment.
  • Patients with brain metastases only.
  • Inability to comply with study and/or follow-up procedures.
  • Unable or unwilling to provide written informed consent.

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): NCT02762877


Locations
Show Show 22 study locations
Sponsors and Collaborators
Genomic Health®, Inc.
  Study Documents (Full-Text)

Documents provided by Genomic Health®, Inc.:
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Responsible Party: Genomic Health®, Inc.
ClinicalTrials.gov Identifier: NCT02762877    
Other Study ID Numbers: 14-009
First Posted: May 5, 2016    Key Record Dates
Results First Posted: November 25, 2019
Last Update Posted: November 17, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms