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

Stopped early

Conditions studied: Non Small Cell Lung Carcinoma

In brief

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)

Key facts

Study ID

NCT02762877

Run by

Genomic Health®, Inc.

People needed

140

Starts

2016-04-01

Expected to finish

2019-06-19

Last updated by the study team

2020-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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