Clinical trial · no report yet · Phase 3
PALOMA-3
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
- NCT05388669 ↗
- Active, not recruiting
- Janssen Research & Development, LLC
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| YouTube | 68 | |
| X threads | 66 | |
| Podcasts | 55 | |
| X videos | 1 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Advanced or Metastatic Non-small Cell Lung Cancer
- Interventions
- Lazertinib; Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF); Amivantamab Intravenous
- Arms
- Arm A: Lazertinib with Amivantamab SC-CF · Experimental
- Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion · Experimental
- Enrollment
- 418
- Primary 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
- For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab
- Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2
- Sponsor
- Janssen Research & Development, LLC
- Start
- Aug 5, 2022
- Primary completion
- Jan 3, 2024
- Results posted
- Yes
- Registry record
- NCT05388669 · updated Sep 28, 2026
Publications
linked from the registry- Leighl NB, Passaro A, Akamatsu H, Spira AI, Nguyen D, Qin A, Schuchard J, Gamil M, Baig M, Alexander M. Plain language summary of subcutaneous vs IV amivantamab plus lazertinib in EGFR-altered non-small-cell lung cancer. Future Oncol. 2026 Aug 24:1-17. doi: 10.1080/14796694.2026.2709936. Online ahead of print. PubMed 42635093
- Leighl NB, Akamatsu H, Lim SM, Cheng Y, Minchom AR, Marmarelis ME, Sanborn RE, Chih-Hsin Yang J, Liu B, John T, Massuti B, Spira AI, Lee SH, Wang J, Li J, Liu C, Novello S, Kondo M, Tamiya M, Korbenfeld E, Moskovitz M, Han JY, Alexander M, Joshi R, Felip E, Voon PJ, Danchaivijitr P, Hsu PC, Silva Melo Cruz FJ, Wehler T, Greillier L, Teixeira E, Nguyen D, Sabari JK, Qin A, Kowalski D, Sendur MAN, Xie J, Ghosh D, Alhadab A, Haddish-Berhane N, Clemens PL, Lorenzini P, Verheijen RB, Gamil M, Bauml JM, Baig M, Passaro A; PALOMA-3 Investigators. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605. doi: 10.1200/JCO.24.01001. Epub 2024 Jun 10. PubMed 38857463