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

NCT02762877 | Terminated Results

• 1 other identifier: 14-009
• Study Type: observational
• Target: 140
• Locations: 7 countries
• Sites: 22

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)

Conditions

Non Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (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

  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 Outcomes (2)

• Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.

  Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks

• Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib).

  Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non small cell lung cancer patients

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.

Sponsors & Collaborators

• Genomic Health®, Inc.: lead

Study Sites (22)

Cancer Care Associates d/b/a Torrance Memorial Physician Network

Torrance, California, 90277, United States

Location

Central Georgia Cancer Care

Macon, Georgia, 31201, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Essex Oncology of North Jersey

Belleville, New Jersey, 07109, United States

Location

Meridian Hospitals

Neptune City, New Jersey, 07753, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

West Clinic

Germantown, Tennessee, 38138, United States

Location

Bon Secours Cancer Institute

Midlothian, Virginia, 23114, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Instituto Nacional del Torax

Santiago, 7500691, Chile

Location

Fundación Arturo López Perez

Santiago, 7500836, Chile

Location

Clinica Alemana de Santiago

Santiago, 7650551, Chile

Location

Centre Jean Perrin

Clermont-Ferrand, Cedex 1, 63011, France

Location

Hôpital Nord

Marseille, Cedex 20, 13915, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33000, France

Location

St. Vincent's University Hospital

Dublin, Elm Park, 4, Ireland

Location

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, 160-0023, Japan

Location

National Cancer Center

Tokyo, Tsukiji, Chuo-ku, 104-0045, Japan

Location

Hospital Universitario Central Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Clatterbridge Cancer Center NHS Foundation Trust

Bebington, Wirral, CH63 4JK, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Genomic Health, Inc.

kgran@genomichealth.com

1.650.569.2042

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 5, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: June 19, 2019
• Last Updated: November 17, 2020
• Results First Posted: November 25, 2019

Record last verified: 2020-11

Locations

ES (3); CL (3); GB (1); IE (1); FR (3); JP (2); US (9)