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: 01 May 2025
Price :
$35
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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
Most Recent Events
- 07 Apr 2025 According to Halozyme Therapeutics media release, based on results from this trial, the European Commission granted marketing authorization of the subcutaneous (SC) formulation of RYBREVANT (amivantamab), in combination with LAZCLUZE (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations.
- 03 Feb 2025 According to the Janssen Cilag Media Release, The CHMP of the EMA has recommended extending the marketing authorization for the SC formulation of RYBREVANT with LAZCLUZE for first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations and as monotherapy for advanced NSCLC with EGFR exon 20 insertions after platinum-based therapy failure. The opinion is supported by positive trial results.
- 03 Feb 2025 Primary endpoint(Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2), has been met, according to the Results presented in Janssen Cilag Media Release.