Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.

NCT ID: NCT03220230

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-06
• Study Completion Date: 2018-10-30

Brief Summary

This is a non-interventional multi-center with investigational sites in Chile and Brasil diagnostic study to validate novel diagnostic technologies, such as Next Generation Sequencing (NGS) from both tissue and blood compared to the current gold standard. As a non-interventional study, patients will receive the treatment indicated by their doctor independently of their participation on this study.

Many cancer cells look the same under the microscope. But as these cells are studied at the molecular level, some genetic alterations or defects that are more common to certain types of cancer are identified. In some cases, these defects are what make the cells grow and multiply abnormally.

Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and that may point to a specific treatment choice.

One of the genetic biomarkers that are believed to cause some cancers to grow is the ALK fusion gene. About 3% to 5% of people with NSCLC may test positive for ALK. ROS1 is a receptor found in 1 to 2% of people with this type of cancer.

The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients.

A positive correlation with these new technologies will mean an efficient, more accurate diagnostic test, which could impact a greater number of cancer patients around world.

Detailed Description

B. Lung Cancer Non-small cell lung cancer (NSCLC) is a common cause of cancer mortality throughout the world. In 2007, there were 1.5 million new lung cancer cases diagnosed worldwide, including around 733,100 cases in the South American Region.6

Approximately 85% of lung cancer is histologically defined as non small cell and the remaining 14% as small cell. The majority of patients with NSCLC present with inoperable locally advanced (Stage IIIB) or metastatic (Stage IV) disease for which no curative treatment is yet available. In newly diagnosed patients with good performance status, platinum based doublet-combination chemotherapies are associated with a median overall survival (OS) of 7.4 to 9.9 months. 7, 8, 9, 10, 11, 12 Therefore, newer agents with novel mechanisms of action are still desperately needed for this serious life-threatening disease. 15,16

The rapid and efficient identification of key driver genes in non-small-cell lung cancer (NSCLC) is becoming increasingly important.17 Clinical screening efforts have revealed that the most common mutations in lung cancer specimens involve EGFR and KRAS, along with 10 other genes that show a prevalence of mutation in 5% or less of tumors. The ALK gene is rearranged in around 3%-5% of patients with NSCLC and has been the focus of intense basic and clinical research, suggesting that the frequency of the gene rearrangement is similar in Asian and Western patients.

ROS1 is a receptor tyrosine kinase of the insulin receptor family. Chromosomal rearrangements involving the ROS1 gene were originally described in glioblastomas, where ROS1 (chromosome 6q22) is fused to the FIG gene (chromosome 6q22 immediately adjacent to ROS1), 16 and have been shown to be transforming in transgenic mice.17 More recently, ROS1 fusions were identified as potential driver mutations in an NSCLC cell line (HCC78; SLC34A2-ROS1) and an NSCLC patient sample (CD74-ROS1). 18 These fusions led to constitutive kinase activity and were associated with sensitivity in vitro and in vivo to crizotinib. As of December 2013, 16 different variants have been found.16, 17, 18

The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients. Advanced next generation sequencing screening methodologies will be used to identify NSCLC patients whose tumors contain a ROS1 gene inversion or translocation or an ALK translocation.

A parallel test for ALK+ by either the Abbott ALK FISH test or the Ventana ALK IHC test is necessary to validate the NGS test in all samples. A parallel test for ROS1+ by either the Kreatech FISH test or the D4D6 ROS1 IHC test may be necessary to validate the NGS test in all samples.

Conditions

Lung Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Female or male, 18 years of age or older.
• Patients with histologically or cytological proven diagnosis of NSCLC, pathologically identified as adenocarcinoma.
• Patient naïve in lung cancer treatment
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the study prior to enrollment.
• Patients must give consent to the research use of their archived or tumor FFPE tissue, and if available, 2 blood tubes.

Exclusion Criteria

• Prior chemotherapy treatment.

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

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Ricardo Armisen, MD, PhD

Role: STUDY_CHAIR

CEMP Pfizer Chile

Locations

Centro Regional Integrado de Oncologia

Fortaleza, Caera, Brazil

Instituto Goiano de Oncología e Hematologia

Aparecida de Goiana, Goiás, Brazil

Hospital Luxemburgo

Belo Horizonte, Minas Gerais, Brazil

Hospital Felicio Rocho

Belo Horizonte /MG, Minas Gerais, Brazil

Instituto de Cancer de Londrina

Londrina, Paraná, Brazil

Centro de Pesquisa da Universidade Federal de Sao Paulo - UNIFESP

São Paulo, VILA Clementino, Brazil

Fundaçao Pio XII, Hospital do Cancer de Barretos

Barretos, , Brazil

Liga Paranaense de Combate ao Cancer Hospital Erasto Gaetner

Curtiba-PR, , Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita

Porto Alegre, , Brazil

Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

Recife, , Brazil

Instituto COI de Pesquisa Educacao e Gestao

Rio de Janeiro, , Brazil

Hospital Da Bahia

Salvador, , Brazil

Hospital Santa Izabel

Salvador, , Brazil

Nucleo de Oncologia da Bahia

Salvador, , Brazil

Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

São Paulo, , Brazil

A.C. Camargo Cancer Center

São Paulo, , Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São Paulo, , Brazil

Hospital Israelita Albert Einstein

São Paulo/SP, , Brazil

Hospital Base de Puerto Montt

Port Montt, Los Lagos Region, Chile

Hospital Base de Valdivia

Valdivia, Los Lagos Region, Chile

Instituto Clinico Oncologico del Sur (ICOS)

Temuco, Ranco, Chile

Centro Internacional de Estudios Clinicos

Santiago, RM, Chile

Hospital Clinico Universidad de Chile, Seccion de Oncologia

Independencia, Santiago, RM, Chile

Hospital Base de Arica

Arica, , Chile

Hosp Regional de Concepcion

Concepción, , Chile

Universidad Católica del Norte

Coquimbo, , Chile

Instituto Nacional Del Torax

Santiago, , Chile

Hospital Carlos Alberto Seguin Escobedo

Arequipa, , Peru

Hospital Nacional Hipolito Unanue

El Agustino, , Peru

Clinica San Felipe

Lima, , Peru

Hospital Central de la Fuerza Aerea Peruana

Lima, , Peru

Instituto Nacional de Enfermedales Neoplasicas (INEN)

Lima, , Peru

Oncosalud

Lima, , Peru

Unidad de Investigacion de la Clinica Internacional - Sede San Borja

Lima, , Peru

Clínica Quirurgica Santa Maria

Lima, , Peru

Centro de Investigación Clínica Trujillo E.I.R.L.

Trujillo, , Peru

Countries

Brazil; Chile; Peru

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=X9001083

To obtain contact information for a study center near you, click here.

Other Identifiers

NIRVANA

Identifier Type: OTHER

Identifier Source: secondary_id

X9001083

Identifier Type: -

Identifier Source: org_study_id