Non-small cell lung cancer, HER2-mutated

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Eric K. Singhi, MD
MD Anderson Cancer Center
Houston, TX, USA

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Amit Kulkarni, MBBS
University of Minnesota
Minneapolis, MN, USA

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

Last updated on 2024-07-23:
3 regimens on this page
4 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.



NCCN


Metastatic disease, all lines of therapy

Carboplatin, Pemetrexed, Pembrolizumab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (DESTINY-Lung04) 2021-ongoing Phase 3 (C) T-DXd TBD if different primary endpoint of PFS

References

  1. DESTINY-Lung04: NCT05048797


Cisplatin, Pemetrexed, Pembrolizumab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (DESTINY-Lung04) 2021-ongoing Phase 3 (C) T-DXd TBD if different primary endpoint of PFS

References

  1. DESTINY-Lung04: NCT05048797


Trastuzumab deruxtecan monotherapy

Regimen variant #1, 5.4 mg/kg

FDA-recommended dose
Study Dates of enrollment Evidence
Goto et al. 2023 (DESTINY-Lung02) 2021-03 to 2022-03 Phase 2 (RT)

Biomarker eligibility criteria

  • HER2 mutations

Antibody-drug conjugate therapy

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
Goto et al. 2023 (DESTINY-Lung02) 2021-03 to 2022-03 Phase 2

Biomarker eligibility criteria

  • HER2 mutations

Antibody-drug conjugate therapy

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 dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT03505710
  2. DESTINY-Lung02: Goto K, Goto Y, Kubo T, Ninomiya K, Kim SW, Planchard D, Ahn MJ, Smit EF, de Langen AJ, Pérol M, Pons-Tostivint E, Novello S, Hayashi H, Shimizu J, Kim DW, Kuo CH, Yang JC, Pereira K, Cheng FC, Taguchi A, Cheng Y, Feng W, Tsuchihashi Z, Jänne PA. Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. J Clin Oncol. 2023 Nov 1;41(31):4852-4863. Epub 2023 Sep 11. Erratum in: J Clin Oncol. 2023 Dec 19;:JCO2302574. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT04644237