Non-small cell lung cancer, HER2-mutated

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	Eric K. Singhi, MD MD Anderson Cancer Center Houston, TX LinkedIn		Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN LinkedIn

Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.

1 regimens on this page 2 variants on this page

Guidelines

ASCO

• 2022: Singh et al. Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline

ESMO

• 2023: Hendriks et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up

Metastatic disease, all lines of therapy

Trastuzumab deruxtecan monotherapy

Regimen variant #1, 5.4 mg/kg

FDA-recommended dose

Study	Dates of enrollment	Evidence
Awaiting publication (DESTINY-Lung02)	2021-ongoing	Phase 2 (RT)

Biomarker eligibility criteria

• HER2 mutations

Antibody-drug conjugate therapy

• Trastuzumab deruxtecan (Enhertu) 5.4 mg/kg IV once on day 1

21-day cycles

Regimen variant #2, 6.4 mg/kg

Study	Dates of enrollment	Evidence
Li et al. 2021 (DESTINY-Lung01)	2018-2020	Phase 2
Awaiting publication (DESTINY-Lung02)	2021-ongoing	Phase 2

Biomarker eligibility criteria

• HER2 mutations

Antibody-drug conjugate therapy

• Trastuzumab deruxtecan (Enhertu) 6.4 mg/kg IV once on day 1

21-day cycles

References

1. DESTINY-Lung01: Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. Epub 2021 Sep 18. link to original article contains dosing details in manuscript link to PMC article PubMed Clinical Trial Registry
2. DESTINY-Lung02: Clinical Trial Registry