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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

LAZCLUZE™ (lazertinib)

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Amivantamab SC, LAZCLUZE - COPERNICUS Study

Last Updated: 04/30/2025

SUMMARY

Amivantamab for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).¹
LAZCLUZE (lazertinib) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).²

COPERNICUS (NCT06667076) is an ongoing, phase 2b, open-label study evaluating the efficacy and safety of amivantamab SC in combination with LAZCLUZE as first-line (1L) treatment, or in combination with platinum-based chemotherapy as second-line (2L) treatment, in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary endpoint is the investigator-assessed progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Enrollment is planned for approximately 330 patients. Results have not yet been published.¹^,³

PRODUCT LABELING

LAZCLUZE (lazertinib) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/LAZCLUZE-pi.pdf.

ONGOING clinical study

COPERNICUS Study

Study Design/Methods

Ongoing, phase 2b, open-label study evaluating the efficacy and safety of amivantamab SC in combination with LAZCLUZE as 1L treatment (cohort 1), or in combination with platinum-based chemotherapy as 2L treatment (cohort 2), in patients with EGFR-mutated locally advanced or metastatic NSCLC.¹^,³
The study design is shown in Figure: COPERNICUS Study Design.
Both cohorts will prophylactically receive enhanced dermatologic adverse event (AE) management, and cohort 1 will receive prophylactic anticoagulation for the first 4 months of treatment.¹ The AE management strategy is shown in Figure: Preventing AEs with Amivantamab.
- Patients also have the option to receive the enhanced administration-related reaction prophylactic regimen from the SKIPPirr study.¹^,⁴

COPERNICUS Study Design¹^,³

A diagram of a key inclusion criteria

AI-generated content may be incorrect.

COPERNICUS (ClinicalTrials.gov Identifier: NCT06667076) enrollment period: December 2024 onwards; estimated study completion: May 23, 2029.
Abbreviations: 1L, first-line; 2L, second-line; AE, adverse event; ANC, absolute neutrophil count; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; eGFR, estimated glomerular filtration rate; Exon19del, exon 19 deletion; icORR, intracranial objective response rate; icPFS, intracranial progression-free survival; ILD, interstitial lung disease; IV, intravenous; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PO, oral; QD, daily; Q3W, every 3 weeks; Q4W, every 4 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; SC, subcutaneous; VTE, venous thromboembolism.
^aPer protocol, while patients with active, untreated brain metastases are excluded, patients with previously treated, stable, or asymptomatic brain metastases are permitted in cohort 1, and patients with any history of brain metastases (no indication for further local therapy) are permitted in cohort 2.
^bIncluding but not limited to hypertension, diabetes, infection, impaired oxygenation, cardiovascular disease, etc.
^cIn 28-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.
^dIn 21-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.

Preventing AEs with Amivantamab¹^,⁴^-⁷

Abbreviations: AE, adverse event; ARR, administration-related reaction; BID, twice daily; VTE, venous thromboembolism.
^aIncludes standard premedication (antihistamines, antipyretics, and glucocorticoids).
^bLa Roche Posay Lipikar AP+M moisturizer was used in COCOON.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 22 April 2025.

References

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1	Halmos B, Florez N, Goldberg S, et al. A phase 2b study of subcutaneous amivantamab with lazertinib as first-line treatment, or with chemotherapy as second-line treatment, for EGFR-mutated non-small cell lung cancer (NSCLC): COPERNICUS. Poster presented at: American Association for Cancer Research (AACR) Annual Meeting; April 25-30, 2025; Chicago, IL.
2	Cho BC, Felip E, Hayashi H, et al. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small cell lung cancer. Future Oncol. 2022;18(6):639-647.
3	Janssen Research & Development, LLC. A phase 2b, open-label, two-cohort study of subcutaneous amivantamab in combination with lazertinib as first-line treatment, or subcutaneous amivantamab in combination with platinum-based chemotherapy as second-line treatment, for common EGFR-mutated locally advanced or metastatic non-small cell lung cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 April 22]. Available from: https://clinicaltrials.gov/study/NCT06667076?term=NCT06667076&rank=1 NLM Identifier: NCT06667076.
4	Spira AI, Paz-Ares L, Han JY, et al. Preventing infusion-related reactions with intravenous amivantamab-results from SKIPPirr, a phase 2 study: a brief report. [published online ahead of print January 24, 2025]. J Thorac Oncol. doi:10.1016/j.jtho.2025.01.018.
5	Leighl NB, Akamatsu H, Lim SM, et al. 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;42(30):3593-3605.
6	Lim SM, Tan JL, Dias JM, et al. Subcutaneous amivantamab and lazertinib as first-line treatment in patients with mutated advanced non-small cell lung cancer (NSCLC): interim results from the phase 2 PALOMA-2 study. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL.
7	Girard N, Li W, Spira AI, et al. Preventing moderate to severe dermatologic adverse events in first-line EGFR-mutant advanced NSCLC treated with amivantamab plus lazertinib: early success of the COCOON trial. Oral Presentation presented at: European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France.