NSCLC KRAS study
Research type
Research Study
Full title
Retrospective cohort study to describe the patient characteristics, treatment patterns, outcomes, and healthcare resource use of non-small cell lung cancer (NSCLC) KRAS mutant or KRAS wild-type patients in the UK
IRAS ID
291837
Contact name
Gary Doherty
Contact email
Sponsor organisation
Amgen (Europe) GmbH
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 2 months, 31 days
Research summary
Specific therapies targeting a common mutation in a gene (KRAS G12C) that happens in patients with non-small cell lung cancer (NSCLC) are currently not available for patients in the UK. There are wide variations in KRAS testing practices to identify the presence of this mutation across sites in routine clinical practice. As a consequence, real-world data about NSCLC patients with this mutation, including their clinical and disease characteristics, how these patients are treated, and their clinical outcomes, is limited.
Several investigational drugs targeting this KRAS mutation are currently in clinical development and the management and prognosis of these patients is expected to change in the future. There is a need to better understand and describe how these specific NSCLC patients are managed today in the local setting, understand the implications of their disease, as well as the healthcare resources they use.
This is a retrospective cohort chart review study in previously treated patients with locally advanced and unresectable or metastatic NSCLC, who have been tested for KRAS gene mutations. The target patient population includes patients confirmed with KRAS G12C mutant tumours, patients with other KRAS mutant tumours ('KRASm-non-G12C’), and patients with KRAS wild-type tumours ('KRAS WT'). This study will focus on retrospective data collection from patient charts, and the data collected will describe these patients in terms of their demographic and clinical characteristics, treatment experience, biomarker testing history, clinical outcomes and healthcare resource utilisation (HRU). There will be no active follow-up of patients in the study.
Up to 17 oncology centres and 17 eligible NSCLC treating physicians will be expected to participate to the study.
The study is sponsored by Amgen, and will be conducted with the support of a clinical research organisation (CRO), Kantar.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0012
Date of REC Opinion
7 Jan 2021
REC opinion
Favourable Opinion