Lead Investigator: Richard Franzese, GlaxoSmithKline
Title of Proposal Research: Assessment of the predictive value of longitudinal circulating tumour deoxyribonucleic acid (ctDNA) dynamics for survival outcomes in non-small-cell lung cancer (NSCLC)
Vivli Data Request: 9821
Funding Source: GSK will fund this research. LAP&P will receive financial compensation for their support of this research. GSK and LAP&P are commercial organizations.
Potential Conflicts of Interest: Richard Charles Franzese is an employee of GSK and owns shares with the company. GSK is a private and for-profit organization. Richard Charles Franzese may have a perceived conflict of interest, such that there may be a perception that GSK wish to influence the research outcomes in a way that may increase their financial gain. Richard Charles Franzese, as an employee and shareholder of GSK, is subject to this risk. Any real or potential conflicts of interest will be managed by ensuring full disclosure of affiliations in publications.
Xiao Ji is an employee of GSK and owns shares with the company. GSK is a private and for-profit organization. Xiao Ji may have a perceived conflict of interest, such that there may be a perception that GSK wish to influence the research outcomes in a way that may increase their financial gain. Xiao Ji, as an employee and shareholder of GSK, is subject to this risk. Any real or potential conflicts of interest will be managed by ensuring full disclosure of affiliations in publications.
Murad Melhem is an employee of GSK and owns shares with the company. GSK is a private and for-profit organization. Murad Melhem may have a perceived conflict of interest, such that there may be a perception that GSK wish to influence the research outcomes in a way that may increase their financial gain. Murad Melhem, as an employee and shareholder of GSK, is subject to this risk. Any real or potential conflicts of interest will be managed by ensuring full disclosure of affiliations in publications.
Sebastiaan Goulooze is an employee of LAP&P. LAP&P is a contract research organization working for GSK. LAP&P and GSK are private and for-profit organizations. Sebastiaan Goulooze may have a perceived conflict of interest, such that there may be a perception that GSK and LAP&P wish to influence the research outcomes in a way that may increase their financial gain. Sebastiaan Goulooze, as an employee of LAP&P and contractor for GSK, is subject to this risk. Any real or potential conflicts of interest will be managed by ensuring full disclosure of affiliations in publications.
Morris Muliaditan is an employee of LAP&P. LAP&P is a contract research organization working for GSK. LAP&P and GSK are private and for-profit organizations. Morris Muliaditan may have a perceived conflict of interest, such that there may be a perception that GSK and LAP&P wish to influence the research outcomes in a way that may increase their financial gain. Morris Muliaditan, as an employee of LAP&P and contractor for GSK, is subject to this risk. Any real or potential conflicts of interest will be managed by ensuring full disclosure of affiliations in publications.
Summary of the Proposed Research:
In 2019, there were >200,000 new cases, and >130,000 deaths from lung cancer in the United States of America. Lung cancer is a disease where cells in the lung grow out of control, forming an abnormal mass of tissue, called a tumor. Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers. Immunotherapy (a type of treatment that uses the body’s own immune system to fight diseases like cancer) alone or in combination with chemotherapy (a treatment for cancer that uses drugs to kill cancer cells or stop them from growing and spreading), is increasingly used as a treatment for NSCLC. Accurately and quickly identifying individuals who may or may not respond to treatment may improve patient outcomes and selection of therapies, particularly when therapies show delayed effectiveness. Decisions to continue therapy, change dosing, or change combinations are best to be informed as early as possible, based on patients’ responses.
Currently the specialists look at the change in tumor size after treatment and the potential appearance of new tumors in the patient (new metastases or spread of the cancer cells) to evaluate the potential positive treatment effects and prognosis of the patient. However, predicting survival for an individual patient remains very difficult. A promising new source of information could be the deoxyribonucleic acid (DNA) from the tumors that can be found circulating in a patient’s blood. The type of DNA (e.g. which mutations, changes in the DNA) and the amount found in the blood could help inform the specialist on the prognosis of the patient and the short-term effectiveness of the current therapy. Linking this shorter-term readout to survival in a predictive framework will be highly beneficial to both patient and health care provider.
This study will use innovative mathematical modelling to describe the amount of circulating tumor DNA and the tumor size over time in patients with NSCLC and how these two relate to the patient’s chances of survival. This will help to evaluate whether circulating tumor DNA can help the doctor to make better treatment decisions compared to the current approach of looking at tumor size alone and link that to the long-term survival benefit early on.
Requested Studies:
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02366143
Sponsor ID: GO29436