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

Non Small Cell Lung Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02762877
• Other study ID #: 14-009
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

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)