MARIPOSA
Research type
Research Study
Full title
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
IRAS ID
286291
Contact name
Martin David Foster
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2020-000743-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is a randomised, multicentre, Phase 3 study to compare the efficacy and safety of combining the investigational medications amivantamab and lazertinib versus osimertinib, a standard treatment, as first-line treatment in participants with epidermal growth factor receptor (EGFR) -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) not amenable to curative therapy (i.e. cancer that has spread outside of the lungs).
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. While osimertinib was a significant advance over earlier EGFR tyrosine kinase inhibitors (TKIs – medications which specifically target this protein in some cancer cells), almost all patients treated with it eventually relapse. There is an unmet need to improve first-line therapy to extend progression-free survival (PFS) beyond the median of 19 months seen with osimertinib.
Participants in the study will be randomised to 1 of 3 study treatments: amivantamab and lazertinib (Arm A), osimertinib only (Arm B) or lazertinib alone (Arm C). Participants in Arms B/C will be blinded to which Arm they are randomised into. The contribution of amivantamab to the activity of the combination will be assessed by comparing the efficacy observed in the amivantamab and lazertinib combination arm (Arm A) with that in the lazertinib monotherapy arm (Arm C).
The study consists of a Screening phase, a Treatment Phase (with 28-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, lost to follow-up, or withdrawal of consent, whichever comes first.
REC name
London - South East Research Ethics Committee
REC reference
20/LO/1020
Date of REC Opinion
18 Sep 2020
REC opinion
Favourable Opinion