Viewing Study NCT03220230



Ignite Creation Date: 2024-05-06 @ 10:19 AM
Last Modification Date: 2024-10-26 @ 12:28 PM
Study NCT ID: NCT03220230
Status: COMPLETED
Last Update Posted: 2019-11-08
First Post: 2017-07-05

Brief Title: Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients
Sponsor: Pfizer
Organization: Pfizer

Study Overview

Official Title: NON INTERVENTIONAL MULTICENTER STUDY FOR THE VALIDATION OF MOLECULAR DIAGNOSTIC TECHNOLOGIES IN SUBJECTS WITH NON SMALL CELL LUNG CANCER NSCLC PROTOCOL N X9001083
Status: COMPLETED
Status Verified Date: 2019-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: NIRVANA
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 15 million new lung cancer cases diagnosed worldwide including around 733100 cases in the South American Region6

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 74 to 99 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 1516

The rapid and efficient identification of key driver genes in non-small-cell lung cancer NSCLC is becoming increasingly important17 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 mice17 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 found16 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NIRVANA OTHER Alias Study Number None