MARIPOSA-2
Research type
Research Study
Full title
A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure
IRAS ID
303839
Contact name
Gary Middleton
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-001825-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 8 days
Research summary
This is a randomised, open-label, multicentre, phase 3 study of amivantamab and lazertinib (the study drugs) in combination with platinum-based chemotherapy (carboplatin and pemetrexed; CP) compared with platinum-based chemotherapy in patients with epidermal growth factor receptor (EGFR) -mutated locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have progressed on or after treatment with osimertinib.
Participants in the study will be randomised to 1 of 3 study treatments: lazertinib, amivantamab, carboplatin, and pemetrexed (“LACP”; Arm A), CP (Arm B) and amivantamab, carboplatin, and pemetrexed (“ACP”; Arm C). Randomisation will be 2:2:1, with a 2 in 5 chance of being selected to Arms A and B, and a 1 in 5 chance of being selected to Arm C.
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 proteins. The purpose of this study is to see if amivantamab and lazertinib, added to standard of care chemotherapy (CP), is safe and useful for treating patients with NSCLC (specifically in patients with the gene abnormality EGFR Exon 19 deletion or Exon 21 L858R substitution) who have received prior treatment for their cancer. This study will look at the effects on lung cancer and any side effects caused by the different treatment options.
The study consists of a Screening Phase (up to 28 days), a Treatment Phase (with 21-day treatment cycles) and a Follow-up Phase. The Follow-up Phase starts after the End of Treatment Visit and continues until the end of study, death, loss to follow-up, or withdrawal of consent, whichever comes first.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0302
Date of REC Opinion
21 Jan 2022
REC opinion
Further Information Favourable Opinion