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

NCT ID: NCT02762877

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-06-19

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)

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.

Conditions

Non Small Cell Lung Carcinoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib)

No interventions assigned to this group

B

Patients with non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genomic Health®, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

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

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-009

Identifier Type: -

Identifier Source: org_study_id