A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Amivantamab is usually given by intravenous infusion, which takes several hours. This study tests a new under-the-skin (subcutaneous) form given with lazertinib in people with EGFR-mutated lung cancer to see if it works as well and is easier to receive.
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
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
- Advanced or Metastatic Non-small Cell Lung Cancer
- Lazertinib
- Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
- Amivantamab Intravenous
- For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State — Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
- For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab — Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
- Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2 — Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.
- Acıbadem Maslak Hospital, Istanbul
Also running at 186 other sites in 20 countries.
Source: ClinicalTrials.gov NCT05388669 · last updated 2026-08-31 · View registry record ↗