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(lazertinib)

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LAZCLUZE® (lazertinib)

Medical Information

Amivantamab SC, LAZCLUZE - COPERNICUS Study

Last Updated: 10/20/2025

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, along with prophylactic supportive care measures for adverse events (AEs), 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 480 patients. Results have not yet been published.1,3,4

PRODUCT LABELING

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.1,3,4 
  • The study design is shown in Figure: COPERNICUS Study Design.
  • Both cohorts will prophylactically receive enhanced dermatologic AE management, and cohort 1 will receive prophylactic anticoagulation for the first 4 months of treatment.1,4 The AE management strategy is shown in Figure: Prophylaxis for Dermatologic AEs and VTE.
    • Patients also have the option to receive the enhanced infusion-related reaction prophylactic regimen from the SKIPPirr study.1,4,5 
  • The following pragmatic measures are being used to eliminate potential barriers to patient enrollment4:
    • One cycle of chemotherapy is permitted while awaiting biopsy results.
    • Only chest scans are required. Scans of other locations are at the investigator’s discretion.
    • Assessment schedules are based on clinical practice.
    • Liquid biopsies are permitted for diagnosis.
    • Broader limits are permitted for organ function and blood count.

COPERNICUS Study Design1,3,4 

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; ctDNA, circulating tumor DNA; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; eGFR, estimated glomerular filtration rate; EMEA, Europe, Middle East, and Africa; 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; PRO, patient-reported outcome; QD, daily; Q3W, every 3 weeks; Q4W, every 4 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; SC, subcutaneous; TKI, tyrosine kinase inhibitor; US, United States; 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.
cCohort 1 includes 300 patients in US and 150 patients in EMEA.
dIn 28-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.
eIn 21-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.

Prophylaxis for Dermatologic AEs and VTE1,4-9

Abbreviations: AE, adverse event; ARR, administration-related reaction; BID, twice daily; ESMO, European Society for Medical Oncology; NCCN, National Comprehensive Cancer Network; VTE, venous thromboembolism.
aIncludes standard premedication (antihistamines, antipyretics, and glucocorticoids).
bProphylactic antibiotics: oral doxycycline or minocycline 100 mg BID and topical clindamycin lotion 1% on the scalp daily before bedtime. Paronychia prophylaxis: chlorhexidine 4% on the fingernails and toenails daily. Skin moisturizer of the body and face at least daily.
cLa 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 17 October 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 October 17]. Available from: https://clinicaltrials.gov/study/NCT06667076 NLM Identifier: NCT06667076.  
4 Halmos B, Florez N, Goldberg S, et al. COPERNICUS: a multinational pragmatic phase 2 trial of subcutaneous amivantamab in common EGFR-mutated NSCLC. e-Poster available at: European Society for Medical Oncology (ESMO) Congress; October 17-21, 2025; Berlin, Germany.  
5 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. J Thorac Oncol. 2025;20(6):809-816.  
6 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.  
7 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.  
8 Cho BC, Li W, Spira AI, et al. Enhanced versus standard dermatologic management with amivantamab-lazertinib in EGFR-mutated advanced NSCLC: the COCOON global randomized controlled trial. J Thorac Oncol. 2025;20(10):1517-1530.  
9 Cho BC, Li W, Spira AI, et al. Supplementary appendix for: Enhanced versus standard dermatologic management with amivantamab-lazertinib in EGFR-mutated advanced NSCLC: the COCOON global randomized controlled trial. J Thorac Oncol. 2025;20(10):1517-1530.