LEPIDOPTERA
Research type
Research Study
Full title
Prospective, Multi‐country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated with Approved Amivantamab-containing Regimens Under Standard Clinical Practice
IRAS ID
361412
Contact name
Raffaele Califano
Contact email
Sponsor organisation
Janssen-Cilag International NV
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This is a prospective, multi-cohort, multicentre, observational study that aims to describe the clinical outcomes and tolerability of amivantamab-containing regimens for the treatment of advanced epidermal growth factor receptor (EGFR; A protein found on certain types of cells that binds to a substance called epidermal growth factor) -mutated non-small cell lung cancer (NSCLC) in a real-world setting. After discontinuation of the amivantamab-containing regimens, patients will be prospectively followed up until end of study or death.
Only data available within standard clinical practice will be collected in this study. Participants will also complete questionnaires concerning their cancer status and quality of life. No other assessments or procedures outside of those performed within standard clinical practice are mandated per protocol.
Participants recruited in this study will be due to receive amivantamab treatment as part of their routine clinical care. Data will be collected from three treatment groups according to their amivantamab-containing treatment:
- Amivantamab with Chemotherapy.
- Amivantamab with Chemotherapy (First-Line Therapy).
- Amivantamab with Lazertinib (First-Line Therapy)The study consists of the following time periods:
- Screening and start of data collection (Up to 4 weeks prior to the start of amivantamab treatment).
- Treatment period (This will continue for as long as the participant receives amivantamab as part of their routine care).
- Follow-up period (This will begin following completion of the routine amivantamab therapy, with information being collected approximately every 8 weeks until the end-of-study).Data collection for a participant will be considered complete at the time of death, or the end of the study, whichever occurs first. The end of the study will be approximately 36 months after the last patient is recruited. The maximum study duration for a participant is therefore approximately 60 months.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0290
Date of REC Opinion
2 Sep 2025
REC opinion
Further Information Favourable Opinion