Clinical trial NCT02762877: Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non Small Cell Lung Carcinoma
Lead sponsor: Genomic Health®, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non small cell lung cancer patients

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.

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.

Primary outcomes:
measure: 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
timeFrame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
Secondary outcomes:
measure: Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.
timeFrame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
measure: Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib).
timeFrame: Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Cancer Care Associates d/b/a Torrance Memorial Physician Network
state: California
city: Macon
country: United States
facility: Central Georgia Cancer Care
state: Georgia
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Belleville
country: United States
facility: Essex Oncology of North Jersey
state: New Jersey
city: Neptune
country: United States
facility: Meridian Hospitals
state: New Jersey
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Midlothian
country: United States
facility: Bon Secours Cancer Institute
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Santiago
country: Chile
facility: Instituto Nacional del Torax
city: Santiago
country: Chile
facility: Fundación Arturo López Perez
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
state: Cedex 1
city: Marseille
country: France
facility: Hôpital Nord
state: Cedex 20
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
state: Elm Park
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
state: Shinjuku-ku
city: Tokyo
country: Japan
facility: National Cancer Center
state: Tsukiji, Chuo-ku
city: Oviedo
country: Spain
facility: Hospital Universitario Central Asturias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Zaragosa
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Bebington
country: United Kingdom
facility: Clatterbridge Cancer Center NHS Foundation Trust
state: Wirral
Study officials:
References: