# A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)

Source: https://onco.cc/trials/nct05388669/  
OnCo record `nct05388669` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Lazertinib in non-small-cell lung cancer and small-cell lung cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT05388669 by Janssen Research & Development, LLC, with 418 participants enrolled, started 2022-08-05 and due to reach its primary completion in 2024-01-03. Interventions recorded: Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous. Conditions listed: Advanced or Metastatic Non-small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: PALOMA-3
- Tags: ctgov-ingest
- Registry id: NCT05388669
- Phase: 3
- Setting: 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
- Sponsor: Janssen Research & Development, LLC
- Enrolled: 418
- Outcomes: 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: Arm A: Lazertinib With Amivantamab SC-CF 206 micrograms per milliliters (mcg/ml) vs Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion 144 micrograms per milliliters (mcg/ml)

## Sources

- ClinicalTrials.gov NCT05388669: https://clinicaltrials.gov/study/NCT05388669

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Lazertinib](https://onco.cc/drugs/lazertinib/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)

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