CATERPILLAR-RWE
Research type
Research Study
Full title
Contemporary systemic anti-cancer therapy effectiveness in patients with advanced/metastatic non-small cell lung cancer harbouring epidermal growth factor receptor Ex20ins treated in European real-world practice; comparison with treatment outcomes of amivantamab in the CHRYSALIS trial cohort D
IRAS ID
296233
Contact name
Sanjay Popat
Contact email
Sponsor organisation
Janssen
Duration of Study in the UK
1 years, 2 months, 16 days
Research summary
This is a multi-country, multi-site, retrospective observational chart review study conducted in Romania, France, Germany, Portugal, Spain, Italy and UK.
The study focuses on patients with advanced/metastatic non-small cell lung cancer harbouring epidermal growth factor receptor Ex20ins and have been treated in clinical practices.
Participant doctors will be asked to retrospectively examine the patients’ medical records for patient eligibility. Patient data will be obtained from the patients medical records and entered into the electronic case report form (eCRF) in an pseudonymised way.
Adult patients with a confirmed diagnosis of locally advanced or metastatic diagnosis of NSCLC (stage IIIB/C or IV, according to TNM editions #7 or #8) between 01 January 2011 and 31 July 2020 who received at least one line of platinum-based therapy any time after or in the 12 months before advanced or metastatic NSCLC diagnosis will be selected.
The study period will range from 01 January 2011 up until 31 May 2021. This is to ensure that patients identified at the end of this window will have at least a minimum of 10 months of follow-up to assess outcomes at the time of data collection.
The index date will be the start of any subsequent line of therapy at the start of which selection criteria are met and the baseline period will allow for collection of all relevant medical history prior to index date.
Patients will be followed up from the index date up until either death of any cause, loss to follow-up or end of the study (31 May 2021).REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0115
Date of REC Opinion
14 Jun 2021
REC opinion
Further Information Favourable Opinion