PALOMA-3
Research type
Research Study
Full title
A Phase 3, Open-label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous on Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-Small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy.
IRAS ID
1005779
Contact name
Scott Banks
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2022-000525-25
Clinicaltrials.gov Identifier
Research summary
This is a 2-part, randomised, open-label, parallel, multi-centre, phase 3 study of lazertinib and amivantamab (the study drugs), in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with a specific mutation in the epidermal growth factor receptor (EGFR) gene, who have progressed on or after treatment with osimertinib and platinum-based chemotherapy (standard treatments for NSCLC). 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.
In this study subcutaneous (SC, under the skin) amivantamab will be administered as a co-formulation (CF) with recombinant human hyaluronidase (rHuPH20). This combination will be abbreviated as SC-CF.
Part 1 of the study will compare the pharmacokinetics (PK, the movement of a drug into, through and out of the body), efficacy (the ability of a drug to provide a beneficial effect), and safety, of combining lazertinib (an oral pill) with amivantamab SC-CF administered via manual injection (Arm A1) versus amivantamab administered intravenously (IV, in the vein; Arm B1).
Part 2 will demonstrate the bioequivalence (the absence of a difference between how amivantamab stays in and acts on the body when administered via different methods) of amivantamab SC-CF administered via manual injection (Arm A2) or via an On Body Delivery System (OBDS, a combination product of a single-use device plus the study drug that is temporarily placed on the abdomen to deliver the drug; Arm B2), combined with lazertinib. The eligibility criteria for Part 1 and Part 2 will be identical.
The study will consist of a Screening Phase (up to 28 days), a Treatment Phase (from randomisation until the End of Treatment Visit [EOT]), and a Follow-up Phase (from EOT until the end of study, death, loss to follow-up, or withdrawal of consent).
REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0507
Date of REC Opinion
23 Sep 2022
REC opinion
Further Information Unfavourable Opinion