Lead Investigator: Si-Cong Ma, The First Affiliated Hospital of Sun Yat-Sen University
Title of Proposal Research: Biomarker-based strategies to enhance efficacy and reduce toxicity in lung cancer immunotherapy
Vivli Data Request: 10158
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Lung cancer is the 2nd most common cancer worldwide. It is the most common cancer in men and the 2nd most common cancer in women. There were more than 2.2 million new cases of lung cancer in 2020. Among them, immune checkpoint blockaded (ICB) immunotherapy is the mainstay treatment of patients. Immune checkpoint blockaded (ICB) therapy works by blocking proteins that stop the immune system from attacking the cancer cells. They allow the immune system to recognize and kill the cancer cells.
Types of ICB include anti-programmed cell death protein 1 (PD-1) and anti-programmed-death-ligand 1 (PD-L1), which are the recommended first treatment of non-small cell lung cancer. However, ICB is only effective for about 30-40% of patients (they are ICB-sensitive). Additionally, patients for whom ICB works often experience undesired side effects, know as immune-related adverse events (irAEs). Previous studies have witnessed that patients with irAEs during ICB therapy are prone to have a better overall survival and response to ICB therapy. However, severe irAEs might lead to patients therapy being stopped, causing reduced quality of life and even death.
Further research is needed to firstly, identify biomarkers (biological molecule found in blood, other body fluids, or tissues) that can be used as a sign to indicate that they will respond to the ICB therapy, which may enhance precision immunotherapy and improve patient outcomes. Secondly, the mechanisms underlying ICB resistance in patients who do not respond to ICB therapy are not well understood; combination strategies, where other therapies are used in combinations with ICB to reverse ICB resistance are not yet fully explored and could expand the population of patients who can benefit from ICB therapy. Thirdly, therapeutic targets and biomarkers for irAEs are urgently needed for monitoring ICB toxicity, in order to prevent severe immune-related adverse events (irAEs) and ensure safer treatment for patients.
This study will obtain biological features of ICB efficacy/toxicity group, search for potential factors related to irAEs and other prognostic indicators, and attempt to predict the outcome of ICB efficacy/toxicity in patients using machine learning methods
Requested Studies:
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Data Contributor: Hoffmann-La Roche
Study ID: NCT02008227
Sponsor ID: GO28915
A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Platinum Failure
Data Contributor: Hoffmann-La Roche
Study ID: NCT01903993
Sponsor ID: GO28753