The IMPULSE study_version 0.1
Research type
Research Study
Full title
IMmune-checkPoint inhibitors (ICI) in non-small cell lUng carcinoma (NSCLC): using moLecular characteriSation of the tumour microenvironment from pre and post immune-modulator treated patient samples to improve Efficacy of the anti-PD-1/PD-L1 class of drugs. Real-world data on the use of ICI within NSCLC patients (IMPULSE study).
IRAS ID
253068
Contact name
Carles/C Escriu Justo
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Lung cancer is the biggest cancer killer globally, and non-small cell lung cancers (NSCLCs) are the largest group of lung cancers. Recent treatment developments have focused on programmed death ligand-1 (PD-1/PD-L1) immune checkpoint inhibitors, but the biological knowledge to effectively predict response is limited to a single validated biomarker which has well documented difficulties in routine practice. Routine clinical use of these inhibitors has only begun in earnest in the last few years, so data pertaining to prediction of response are limited, but vitally important to acquire. This study will collect and collate retrospectively clinical outcome data with routine histopathological and molecular data from patient surplus samples pre and post treatment with PD-1/PD-L1 immune checkpoint inhibitors. A cohort of this type will allow further exploration of molecular and genetic features based on contemporary findings to help build a more detailed understanding of the mechanism that explains why certain patients/tumours do or do not respond to these therapies. It is hoped that combining the findings of ongoing research based on the natural history of NSCLC tumour evolution with patients who have actually had treatment and have clinical outcome data, a solid correlation between clinical/molecular/genetic features and response to therapy can be made. In so doing a model that helps to more accurately predict response to these therapies before they are treated can be developed, which would minimise patient risk, maximise patient outcome and save money.
In addition, most of data available on the efficacy and tolerance of ICI is based on clinical trials which not always represent routine practice. By using a cohort of real-world patients, we will be able to compare our results from those reported in pivotal trials aiming to identify unmet clinical needs and challenges of the use of this drug in common practice.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0091
Date of REC Opinion
2 Apr 2020
REC opinion
Favourable Opinion