Trial Profile

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 14 May 2026

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At a glance

Drugs Amivantamab (Primary) ; Amivantamab (Primary) ; Hyaluronidase (Primary) ; Lazertinib (Primary)
Indications Non-small cell lung cancer
Focus Pharmacokinetics; Registrational
Acronyms PALOMA-3
Sponsors Janssen Research & Development; Janssen-Cilag

31 Mar 2026 This trial has been completed in Germany and Portugal.
05 Mar 2026 Planned End Date changed from 30 Jun 2026 to 30 Jun 2027.
17 Feb 2026 According to Johnson & Johnson media release, company announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj).

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