PAPILLON
Research type
Research Study
Full title
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
IRAS ID
288253
Contact name
Sanjaykumar Popat
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-000633-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This is a randomised, open-label phase 3 study of the investigational medication amivantamab in combination with standard care carboplatin-pemetrexed therapy (chemotherapy), compared with carboplatin-pemetrexed alone, in patients with epidermal growth factor receptor (EGFR) Exon 20 insertion mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
The purpose of this study is to see if amivantamab, in combination with the administration of standard of care chemotherapy is safe and useful for treating patients with NSCLC, specifically in patients with a gene abnormality called EGFR Exon 20 insertions. EGFR is a protein that is present on the surface of all cells, including cancer cells. An EGFR mutation refers to a damage to the portion of the DNA in a lung cancer cell which holds the formula for producing EGFR (epidermal growth factor receptor) proteins. In approximately 10% of patients with EGFR-mutated NSCLC, EGFR is activated through one of a group of genetic insertions in EGFR Exon 20, which are collectively referred to as EGFR Exon 20 insertion (Exon 20ins) mutations. This study will look at the effects on lung cancer and any side effects caused by amivantamab in combination with chemotherapy or chemotherapy alone.
Participants in the study will be randomised to receive either amivantamab in combination with pemetrexed and carboplatin (Arm A) or pemetrexed and carboplatin alone (Arm B). The study will consist of a Screening Phase, a Treatment Phase and a Follow-up Phase.
Participants in Arm B may also cross over to amivantamab monotherapy (i.e. amivantamab alone) after disease progression.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/1180
Date of REC Opinion
4 Jan 2021
REC opinion
Further Information Favourable Opinion