Non-small cell lung cancer, HER2-mutated
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| Page editor | Section editor | ||
|---|---|---|---|
 |
Eric K. Singhi, MD MD Anderson Cancer Center Houston, TX, USA |
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Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN, USA |
Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.
3 regimens on this page
4 variants on this page
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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.
ASCO
- 2022: Singh et al. Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline PubMed
ESMO
- 2023: Hendriks et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up PubMed
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Non-Small Cell Lung Cancer.
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
- 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
- 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
- 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 |
| Goto et al. 2023 (DESTINY-Lung02) | 2021-03 to 2022-03 | 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
- 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 NCT03505710
- 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 contains dosing details in manuscript PubMed NCT04644237