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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02762877
Other study ID # 14-009
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2016
Est. completion date June 19, 2019

Study information

Verified date November 2020
Source Genomic Health®, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Terminated
Enrollment 140
Est. completion date June 19, 2019
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Chile Clinica Alemana de Santiago Santiago
Chile Fundación Arturo López Perez Santiago
Chile Instituto Nacional del Torax Santiago
France Polyclinique Bordeaux Nord Aquitaine Bordeaux
France Centre Jean Perrin Clermont-Ferrand Cedex 1
France Hôpital Nord Marseille Cedex 20
Ireland St. Vincent's University Hospital Dublin Elm Park
Japan National Cancer Center Tokyo Tsukiji, Chuo-ku
Japan Tokyo Medical University Hospital Tokyo Shinjuku-ku
Spain Hospital Universitario Central Asturias Oviedo
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Clinico Universitario Lozano Blesa Zaragosa
United Kingdom Clatterbridge Cancer Center NHS Foundation Trust Bebington Wirral
United States Essex Oncology of North Jersey Belleville New Jersey
United States Gabrail Cancer Center Canton Ohio
United States West Clinic Germantown Tennessee
United States Central Georgia Cancer Care Macon Georgia
United States Bon Secours Cancer Institute Midlothian Virginia
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States Meridian Hospitals Neptune New Jersey
United States MultiCare Health System Tacoma Washington
United States Cancer Care Associates d/b/a Torrance Memorial Physician Network Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Genomic Health®, Inc.

Countries where clinical trial is conducted

United States,  Chile,  France,  Ireland,  Japan,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
Secondary Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue. 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. Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
Secondary Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib). 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 Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)
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